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+-----------------------------------------------------------------------------------------------------------------------+
| ![Woman in red jacket with pink purse walking][image0] |
| |
| ![Woman in red jacket with pink purse walking][image1] |
+-----------------------------------------------------------------------------------------------------------------------+
| This site is intended for U.S. Healthcare Providers |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Weight\ |
| Reduction** |
| ================== |
+-----------------------------------------------------------------------------------------------------------------------+
| true |
+-----------------------------------------------------------------------------------------------------------------------+
| Explore clinical data for weight reduction with Zepbound**®** (tirzepatide) injection. |
+-----------------------------------------------------------------------------------------------------------------------+
| [Explore Access and Affordability](/hcp/coverage-savings "Access coverage support") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| true |
+-----------------------------------------------------------------------------------------------------------------------+
| ON THIS PAGE |
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+-----------------------------------------------------------------------------------------------------------------------+
| Who is Zepbound for? |
| |
| Learn who Zepbound is for |
| |
| who\_zepbound |
+-----------------------------------------------------------------------------------------------------------------------+
| Clinical data |
| |
| Learn about clinical data for Zepbound |
| |
| clinical\_data |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+----------------------------+
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---
+---------------------------------------------------------------------------------------------------------------------------+
| Promo Banner (left, highlight color secondary, title fs 36px, titlestyle ringside, link, sametab, select) |
+---------------------------------------------------------------------------------------------------------------------------+
| ### WHO IS ZEPBOUND FOR? |
+---------------------------------------------------------------------------------------------------------------------------+
| For adults with obesity, or with overweight in the presence of at least one weight-related comorbid condition, in |
| combination with a reduced-calorie diet and increased physical activity.1\ |
| \ |
| \_Zepbound\_ is proven to help adults with obesity achieve significant weight loss and maintain it long term.1 |
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---
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| Anchor Links (heading fs 14px) |
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| CLINICAL DATA |
+--------------------------------------------+
| |
+--------------------------------------------+
| SURMOUNT-1 Efficacy |
| |
| efficacy\_section |
+--------------------------------------------+
| SURMOUNT-1 Pre-Specified Subgroup Analysis |
| |
| efficacy-65 |
+--------------------------------------------+
| Cardiometabolic Parameters |
| |
| cardiometabolic\_parameters |
+--------------------------------------------+
| SURMOUNT-4 Efficacy |
| |
| surmount-4 |
+--------------------------------------------+
| SURMOUNT-5 Efficacy |
| |
| surmount-5 |
+--------------------------------------------+
| SURMOUNT-MAINTAIN Efficacy |
| |
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| Study Designs |
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+----------------------------------------------------------------------------------------------------------------------+
| ![Woman in green dress sitting at a table][image2] |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 |
+----------------------------------------------------------------------------------------------------------------------+
| ### Powerful reductions in body weight1 |
+----------------------------------------------------------------------------------------------------------------------+
| With a single dose escalation, 2.5 mg for 4 weeks then 5 mg, Zepbound's lowest maintenance dose delivered an average |
| 15% body weight reduction vs 3.1% with placebo at 72 weeks.2\ |
| \ |
| At 15 mg, Zepbound-treated adults achieved an average weight reduction of almost 21% of their body weight vs 3.1% |
| with placebo at 72 weeks, \~7x more powerful than placebo.2 |
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| **Percentage change in body weight over time from baseline to week 721,3,4** |
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| ![Overall percentage changes in body weight from baseline at 72 weeks][image3] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Overall percentage changes in body weight from baseline at 72 weeks][image4] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Line graph showing the percentage change in body weight over time from baseline to 72 weeks in the SURMOUNT-1 trial |
| (Zepbound 5 mg, 10 mg, and 15 mg vs placebo). There were 630, 636, 630, and 643 total adults given Zepbound 5 mg, 10 |
| mg, 15 mg, and placebo, respectively, at the start of the trial. There were 601, 593, 595, and 593 total adults given |
| Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively, at 20 weeks. There were 579, 584, 582, and 522 total adults |
| given Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively, at 48 weeks. There were 566, 569, 571, and 504 total |
| adults given Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively, at 72 weeks. There were 630, 636, 630, and 643 |
| total adults given Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively, at 72 weeks with hybrid imputation. The |
| mean baseline weights were 226.8 lb for Zepbound 5 mg, 233.3 lb for Zepbound 10 mg, 232.8 lb for Zepbound 15 mg, and |
| 231\.0 lb for placebo. The observed mean percentage change in body weight at 72 weeks post randomization was -15.0% |
| for Zepbound 5 mg, -19.5% for Zepbound 10 mg, and -20.9% for Zepbound 15 mg vs -3.1% for placebo. |
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.1**\ |
| \ |
| Coprimary Endpoint: Percentage change in body weight over time from baseline to week 72.\ |
| \ |
| **Zepbound is not indicated for cosmetic weight loss.**\ |
| Both Zepbound and placebo treatment were adjunct to reduced-calorie diet and increased physical activity.\ |
| P<0.001 for superiority of Zepbound vs placebo, controlled for type I error.1\ |
| \ |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity, excluding type 2 diabetes.1\ |
| \ |
| The percentage change in body weight by dose (Zepbound 10 mg and 15 mg) was a coprimary endpoint.2\ |
| \ |
| ITT population includes all randomly assigned patients. Data represent observed mean percent changes in body weight from week 0 to 72 and least-squares mean percent change at week 72. ANCOVA was |
| performed for percent weight change from baseline at week 72 with hybrid imputation.1\ |
| \ |
| In a separate weight-reduction study of adults with a BMI of ≥27 kg/m2 and type 2 diabetes, the overall percentage change in body weight from baseline at 72 weeks was -12.8% (10 mg), |
| -14.7% (15 mg), and -3.2% (placebo). Mean baseline weights were 222.4 lb (10 mg), 219.6 lb (15 mg), and 224.2 lb (placebo).1,3\ |
| \ |
| The proportions of patients who discontinued treatment in SURMOUNT-1 were 14.3%, 16.4%, and 15.1% for the 5 mg, 10 mg, and 15 mg Zepbound-treated groups, respectively, and 26.4% for the |
| placebo-treated group.1\ |
| \ |
| The proportions of patients who discontinued treatment in SURMOUNT-2 were 9.3% and 13.8% for the 10 mg and 15 mg Zepbound-treated groups, respectively, and 14.9% for the placebo-treated group.1\ |
| \ |
| **[DOSAGE AND ADMINISTRATION](/hcp/dosage)** |
| |
| - **The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.** |
| - **Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.** |
| - **Follow the dosage escalation as described in the US Prescribing Information to reduce the risk of gastrointestinal adverse reactions.** |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; HI=hybrid imputation; ITT=intent-to-treat; MMRM=mixed model for repeated measures. |
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+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Study Design](https://zepbound.lilly.com/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
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+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Pre-Specified Subgroup Analysis](https://zepbound.lilly.com/hcp/clinical-data-weight#efficacy-65 "iew Zepbound Efficacy in Participants 65 or Older") |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-4 Efficacy](https://zepbound.lilly.com/hcp/clinical-data-weight#surmount-4 "iew Zepbound Efficacy in Participants 65 or Older") |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
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+------------------------------------------------------------------------------------------------------------------------------------------------+
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+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| [Zepbound vs Wegovy® (semaglutide)](https://zepbound.lilly.com/hcp/clinical-data-weight#zepbound-to-wegovy "Zepbound vs Wegovy® (semaglutide)") |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Safety](https://zepbound.com/hcp/clinical-data-weight#safety_section "Surmount-1 Safety") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **CONTRAINDICATIONS\ |
| Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in |
| patients with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious |
| hypersensitivity reactions including anaphylaxis and angioedema have been reported with tirzepatide.** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
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+-----------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 |
+-----------------------------------------------------------------------------------------------------------------+
| #### Weight reductions observed on Zepbound 5 mg1 |
+-----------------------------------------------------------------------------------------------------------------+
| 30% of adults taking Zepbound 5 mg experienced ≥20% weight reduction1\* |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
+-------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Secondary endpoint: percentage of adults who achieved ≥5%, ≥10%, and ≥20% weight reduction from baseline to week 72 |
| at 5 mg1,3** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| ![Bar charts of participants who lost weight for different doses of Zepbound][image6] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Bar charts of participants who lost weight for different doses of Zepbound][image7] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| 3 bar graphs showing the percentage of adults who had ≥5% (adjusted for type 1 error), ≥10%, and ≥20% (not adjusted |
| for type 1 error) weight loss in the SURMOUNT-1 trial (Zepbound 5 mg vs placebo at 72 weeks). There were 630 and 643 |
| total adults for Zepbound 5 mg and placebo, respectively. The mean baseline weights were 226.8 lb for Zepbound 5 mg |
| and 231.0 lb for placebo. The percentage of adults achieving ≥5% weight loss was 85.1% for Zepbound 5 mg vs 34.5% for |
| placebo. The percentage of adults achieving ≥10% weight loss was 68.5% for Zepbound 5 mg vs 18.8% for placebo. The |
| percentage of adults achieving ≥20% weight loss was 30% for Zepbound 5 mg vs 3.1% for placebo. |
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| |
+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.1**\ |
| \ |
| The Zepbound group for ≥5% weight loss was P<0.001 for superiority vs placebo, controlled for type I error.1\ |
| \ |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity, excluding type 2 diabetes.1\ |
| \ |
| ITT population includes all randomly assigned patients. The missing values were imputed by a hybrid approach using retrieved dropouts from the same treatment group (if missing not due to |
| COVID-19) or using all non-missing data assuming missing at random (for missing solely due to COVID-19). Analyzed using logistic regression adjusted for baseline value and other stratification |
| factors.1\ |
| \ |
| The proportions of patients who discontinued treatment in SURMOUNT-1 were 14.3%, 16.4%, and 15.1% for the 5 mg, 10 mg, and 15 mg Zepbound-treated groups, respectively, and 26.4% for the |
| placebo-treated group.1\ |
| \ |
| \*≥10% and ≥20% weight reductions were NOT controlled for type I error. |
+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; COVID-19=coronavirus disease 2019; ITT=intent-to-treat. |
+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Study Design](https://zepbound.lilly.com/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety_section "View SURMOUNT-1 Safety") |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Get a patient started on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Risk of Thyroid C-cell Tumors**\ |
| Counsel patients regarding the potential risk for MTC with the use of Zepbound and inform them of symptoms of thyroid |
| tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin |
| or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Zepbound. Such |
| monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and |
| a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and |
| patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, |
| the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging |
| should also be further evaluated. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 |
+-----------------------------------------------------------------------------------------------------------------------+
| #### \~1 in 3 adults lost ≥25% (58 lb)\* on Zepbound 10 mg and Zepbound 15 mg6 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| **Exploratory endpoint: percentage of adults who achieved ≥25% weight reduction from baseline to week 722,6** |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------+
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| ![Secondary Endpoint: Percentage of adults who achieved ≥10% and ≥20% weight reduction from baseline to week 72][image8] |
+--------------------------------------------------------------------------------------------------------------------------+
| ![Weight loss percentages for 10mg, 15mg and placebo Zepbound][image9] |
+--------------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Bar graph showing the percentage of adults who had ≥25% weight loss in the SURMOUNT-1 trial (Zepbound 5 mg, 10 mg, and |
| 15 mg vs placebo at 72 weeks). There were 630, 636, 630, and 643 total adults for Zepbound 5 mg, 10 mg, 15 mg, and |
| placebo, respectively. The mean baseline weights were 226.8 lb for Zepbound 5 mg, 233.3 lb for Zepbound 10 mg, 232.8 lb |
| for Zepbound 15 mg, and 231.0 lb for placebo. The percentage of adults achieving ≥25% weight loss was 15.3% for Zepbound |
| 5 mg, 32.3% for Zepbound 10 mg, and 36.2% for Zepbound 15 mg vs 1.5% for placebo. |
+--------------------------------------------------------------------------------------------------------------------------+
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| |
+--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.1**\ |
| \ |
| \*25% weight loss from mean baseline weight was 58 lb.\ |
| \ |
| This was an exploratory endpoint and was not adjusted for type I error.2\ |
| \ |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity, excluding type 2 diabetes.1\ |
| \ |
| In a separate weight-reduction study of adults with a BMI of ≥27 kg/m2 and type 2 diabetes, percent of patients losing ≥25% Zepbound 10 mg and Zepbound 15 mg was 9% and 15%, |
| respectively vs <1% for placebo. Mean baseline weights were 222.4 lb (10 mg), 219.6 lb (15 mg), and 224.2 lb (placebo). This was an exploratory endpoint not controlled for type 1 error.7\ |
| \ |
| ITT population includes all randomly assigned patients. The missing values were imputed by a hybrid approach using retrieved dropouts from the same treatment group (if missing not due to |
| COVID-19) or using all non-missing data assuming missing at random (for missing solely due to COVID-19). Analyzed using logistic regression adjusted for baseline value and other stratification |
| factors.2\ |
| \ |
| The proportions of patients who discontinued treatment in SURMOUNT-1 were 14.3%, 16.4%, and 15.1% for the 5 mg, 10 mg, and 15 mg Zepbound-treated groups, respectively, and 26.4% for the |
| placebo-treated group.1 |
+--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; COVID-19=coronavirus disease 2019; ITT=intent-to-treat. |
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| |
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| |
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+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Study Design](https://zepbound.lilly.com/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety_section "View SURMOUNT-1 Safety") |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Get a patient started on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Severe Gastrointestinal Adverse Reactions**\ |
| Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In a pool of two |
| Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions were reported more |
| frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates |
| of severe gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight reduction and in |
| Zepbound clinical trials for obstructive sleep apnea (OSA). Severe gastrointestinal adverse reactions have also been |
| reported postmarketing with GLP-1 receptor agonists. Zepbound is not recommended in patients with severe |
| gastroparesis. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
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+--------------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 PRE-SPECIFIED SUBGROUP ANALYSIS |
+--------------------------------------------------------------------------------------------------------------------------------------+
| Mean percentage change in body weight from baseline to week 72 in participants aged 65 and over taking Zepbound8 |
+--------------------------------------------------------------------------------------------------------------------------------------+
| Mean percentage change in body weight from baseline to week 72 for a total of 152 adults were -14.1% with Zepbound 5 mg |
| (n=52), -18.0% with Zepbound 10 mg (n=31), and -20.3% with Zepbound 15 mg (n=35), compared to -4.8% with placebo (n=34).8 |
+--------------------------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Mean percentage change in body weight from baseline to week 72 in participants aged 65 and older8** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| ![Mean percentage change in body weight from baseline to week 72 in participants aged 65 and older.][image10] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Mean percentage change in body weight from baseline to week 72 in participants aged 65 and older.][image11] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Bar graph showing the mean percentage change in body weight from baseline to week 72 in participants aged 65 and |
| older. For participants taking Zepbound 5 mg (n=52; mean baseline weight=220.9 pounds), the mean percentage change |
| was -14.1% (-31.3 pounds). For participants taking Zepbound 10 mg (n=31; mean baseline weight=217.8 pounds), the mean |
| percentage change was -18.0% (-39.0 pounds). For participants taking Zepbound 15 mg (n=35; mean baseline weight=217.4 |
| pounds), the mean percentage change was -20.3% (-44.6 pounds). For participants taking placebo (n=34; mean baseline |
| weight=217.0 pounds), the mean percentage change was -4.8% (-9.0 pounds). |
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.1**\ |
| \ |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbid condition, excluding type 1 or type 2 diabetes.1 |
| |
| In a pool of two fixed-dose Zepbound clinical studies for weight reduction (SURMOUNT-1 and SURMOUNT-2), 226 (9%) Zepbound-treated participants were 65 years of age or older, and 13 (0.5%) Zepbound-treated |
| participants were 75 years of age or older at baseline.1 |
| |
| No overall differences in safety or effectiveness of Zepbound have been observed between participants 65 years of age and older and younger adult participants.1 |
| |
| Study Limitations: |
| |
| This was a prespecified sub‑group analysis among the secondary endpoints of the SURMOUNT‑1 study. The analyses were not adjusted for type I error. |
| |
| TRE data: descriptive statistics based on observed values. Modified intent-to-treat (mITT) population includes all randomly assigned participants who are exposed to at least 1 dose of study drug. Full analysis |
| set includes data obtained during treatment period from mITT, regardless of adherence to study drug.8 |
| |
| Missing values were imputed based on observed data in the same treatment arm from participants who had their efficacy measure at the endpoint visit assessed after early discontinuation of study drug (retrieved |
| dropouts) if missing is not due to COVID-19; or were imputed by predictions using observed data from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline \+ |
| Analysis Country \+ Sex \+ Prediabetes Status at Randomization \+ Treatment \+ Time \+ Treatment\*Time (with variance-covariance structure = Heterogeneous Toeplitz), if missing solely due to COVID-19.8 |
| |
| Least-squares mean from analysis of covariance (ANCOVA) adjusted for baseline value and other stratification factors.8 |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index. |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Acute Kidney Injury Due to Volume Depletion**\ |
| There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients |
| treated with GLP‑1 receptor agonists, or Zepbound. The majority of the reported events occurred in patients who |
| experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor |
| renal function in patients reporting adverse reactions to Zepbound that could lead to volume depletion, especially |
| during dosage initiation and escalation of Zepbound. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| ### **Cardiometabolic Parameters** |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------+
+------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 |
+-----------------------------------------------------------------------------------------------------------------------+
| #### Improvements in cardiometabolic parameters at 72 weeks2,9 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Secondary endpoints: pooled Zepbound 5 mg, 10 mg, and 15 mg from baseline to week 721,2,9,10** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Weight loss percentages for 10mg, 15mg and placebo Zepbound][image12] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Weight loss percentages for 10mg, 15mg and placebo Zepbound][image13] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Image of the secondary endpoints: cardiometabolic measures. Adjusted for type 1 error: HDL cholesterol, systolic |
| blood pressure, and triglycerides. HDL cholesterol: 8.0% increase with Zepbound vs a 0.7% reduction with placebo. |
| (Baseline was 47.6 mg/dL with Zepbound vs 46.6 mg/dL with placebo). Systolic blood pressure: 7.2 mm Hg reduction with |
| Zepbound vs a 1.0 mm Hg reduction with placebo. (Baseline was 123.5 mm Hg with Zepbound vs 122.9 mm Hg with placebo). |
| Triglycerides: 24.8% reduction with Zepbound vs a 5.6% reduction with placebo. (Baseline was 127.5 mg/dL with |
| Zepbound vs 130.8 mg/dL with placebo).\ |
| \ |
| Not adjusted for type 1 error: LDL cholesterol and diastolic blood pressure. LDL cholesterol: 5.8% reduction with |
| Zepbound vs a 1.7% reduction with placebo. (Baseline was 110.1 mg/dL with Zepbound vs 109.4 mg/dL with placebo). |
| Diastolic blood pressure: 4.8 mm Hg reduction with Zepbound vs a 0.8 mm Hg reduction with placebo. (Baseline was 79.5 |
| mm Hg with Zepbound vs 79.6 mm Hg with placebo).\ |
| \ |
| Zepbound is not indicated for hypertension or dyslipidemia. |
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.1** |
| |
| At 72 weeks, participants in the pooled Zepbound arm had a mean pulse rate increase of 1.8 beats/minute compared to a mean baseline of 72.2 beats/minute. The placebo arm has a mean pulse rate |
| increase of 0.1 beats/minute compared to a mean baseline of 72.9 beats/minute. Results were not adjusted for type I error.1,10 |
| |
| Changes in HDL cholesterol, systolic blood pressure, and triglycerides for pooled Zepbound were significant at P<0.001 for superiority vs placebo.2 |
| |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity, excluding type 2 diabetes.1 |
| |
| ITT population includes all randomly assigned patients. The missing values were imputed by a hybrid approach using retrieved dropouts from the same treatment group (if missing not due to |
| COVID-19) or using all non-missing data assuming missing at random (for missing solely due to COVID-19). Least-squares mean from ANCOVA adjusted for baseline value and other stratification |
| factors.1 |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; COVID-19=coronavirus disease 2019; HDL=high-density lipoprotein; ITT=intent-to-treat; LDL=low-density lipoprotein. |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety_section "View SURMOUNT-1 Safety") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Get a patient started on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Acute Gallbladder Disease**\ |
| Treatment with Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder |
| disease. In a pool of two clinical trials of Zepbound (SURMOUNT-1 and SURMOUNT-2), cholelithiasis was reported in |
| 1\.1% of Zepbound-treated patients and 1.0% of placebo-treated patients, cholecystitis was reported in 0.7% of |
| Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of |
| Zepbound-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight |
| reduction. Similar rates of cholelithiasis were reported in Zepbound clinical trials for weight reduction and in |
| Zepbound trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical |
| follow-up are indicated. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+-----------------------------------------------------------------+
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+-------------------------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-4 |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| #### Participants on Zepbound maintained weight loss through 88 weeks versus weight regain for those switched to placebo at week 361 |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------+
+-----------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| ### **Percentage change in body weight over time1,11-13** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| ![Percentage change in body weight over time][image14] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Percentage change in body weight over time][image14] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Line graph depicting percentage change in body weight over time from baseline to 88 weeks comparing people who |
| continued taking Zepbound MTD (10 mg or 15 mg) at 36 weeks vs people who stopped taking Zepbound at 36 weeks. There |
| were 670 patients enrolled, and the overall mean baseline weight was 236.6 lbs. At 36 weeks, the average weight |
| change was -20.9%. From week 36 to 88, the average weight change was -5.5% for the patients who continued with |
| Zepbound MTD (n=335) and \+14.0% for the patients who switched to placebo at week 36 (n=335). From week 0 to week 88, |
| patients who continued Zepbound treatment experienced a weight change of -25.8%a vs -9.5%a in |
| those who switched to placebo at week 36. Treatment and placebo included a reduced-calorie diet and increased |
| physical activity. |
+-----------------------------------------------------------------------------------------------------------------------+
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| |
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+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| Treatment and placebo included a reduced-calorie diet and increased physical activity.1\ |
| \ |
| The mean percentage change in body weight for Zepbound MTD (10 mg or 15 mg) versus placebo was the primary endpoint.1 |
| |
| aHybrid imputation least-square mean values at week 88 were -25.3% for Zepbound MTD and -9.9% for those who switched |
| to placebo at week 36.\ |
| bZepbound MTD was either 10 mg or 15 mg. |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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| |
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+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| P<0.001 for superiority of Zepbound vs placebo, controlled for type I error.1\ |
| \ |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at |
| least 1 weight-related comorbidity (excluding type 2 diabetes) as an adjunct to a reduced-calorie diet and increased |
| physical activity.1\ |
| \ |
| During the open-label period (week 0 to week 36, including a 20-week dose escalation period), 783 participants were |
| enrolled and received Zepbound. At week 36, 670 participants were randomized to receive either a maximum tolerated dose of |
| Zepbound or placebo.1\ |
| \ |
| Data represent observed mean values from week 0 to week 88 for the full analysis set. The -5.5% and \+14% reflect |
| least-squares mean from ANCOVA adjusted for baseline (randomization) values and other stratification values.13\ |
| \ |
| Of the 783 patients who started Zepbound at week 0, 113 patients (14.4%) discontinued treatment before randomization at |
| week 36, and adverse events were the most common reason for discontinuation (n=53, 6.8%).1\ |
| \ |
| The proportions of patients who discontinued study drug after randomization (week 36) in SURMOUNT-4 were 10.4% for the |
| Zepbound-treated group and 17.9% for the placebo-treated group.1 |
+----------------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; ITT=intent-to-treat; MTD=maximum tolerated dose. |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-4 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-4 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Efficacy](/hcp/clinical-data-weight#surmount-maintain "View SURMOUNT-MAINTAIN Efficacy") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Acute Pancreatitis**\ |
| Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in |
| patients treated with GLP-1 receptor agonists, or Zepbound. After initiation of Zepbound, observe patients carefully |
| for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes |
| radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, |
| discontinue Zepbound and initiate appropriate management. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------+
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---
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---
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+------------------------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-5 |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| #### An open-label, head-to-head trial comparing Zepbound® (10 mg or 15 mg) to Wegovy® (semaglutide) injection (1.7 mg or 2.4 mg)14 |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| Primary endpoint was met at 72 weeks |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
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---
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| ### **Primary endpoint: percent change in weight from baseline to week 7214-17** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| ![Mean percentage change in body weight from baseline to week 72][image15] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Change in Body weight Mean percentage change in body weight from baseline to week 72 with Zepbound][image16] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Line graph showing the percentage change in body weight from baseline to week 72 in the SURMOUNT-5 trial (Zepbound |
| MTD \[10 or 15 mg] vs Wegovy MTD \[1.7 or 2.4 mg]). There were 374 total adults for Zepbound and 376 total adults for |
| Wegovy. The percentage change in body weight at week 72 was -20.2% (-50.3 lbs) for Zepbound vs -13.7% (-33.1 lbs) for |
| Wegovy. |
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+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| **Both Zepbound and Wegovy treatment arms included a reduced-calorie diet and increased physical activity.14**\ |
| \ |
| aP<0.001 for superiority of Zepbound vs Wegovy, controlled for type I error.14\ |
| \ |
| bNot controlled for type I error.15\ |
| \ |
| mITT population includes all randomly assigned participants exposed to at least 1 dose of study intervention. The missing values were imputed |
| using retrieved dropouts from the same treatment group. Least-squares mean from ANCOVA adjusted for baseline value and other stratification |
| factors.14\ |
| \ |
| **Wegovy 7.2 mg was not evaluated in this study and has since been approved.**\ |
| \ |
| The proportion of adults who discontinued the study drug due to adverse events was 6.1% for the Zepbound-treated group and 8.0% for the |
| Wegovy-treated group.14\ |
| \ |
| Studied in a randomized, open-label, phase 3b trial of adults who had obesity (BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2) |
| with at least 1 weight-related comorbidity, excluding type 2 diabetes. The study included a 2-week screening period and a 72-week treatment |
| period. Mean baseline weight was 248.4 lb for Zepbound MTD (10 mg or 15 mg) and 250.0 lb for Wegovy MTD (1.7 mg or 2.4 mg).14,16\ |
| \ |
| **Limitations of an open-label study may be related to a bias in evaluation of the outcomes, efficacy and/or safety, and the study did not have a |
| comparison with placebo.** |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; mITT=modified intent-to-treat; MTD=maximum tolerated dose. |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-5 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-5 Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety_section-5 "View SURMOUNT-5 Safety") |
+-------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Get a patient started on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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| |
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+----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
+----------------------------------------------------------------------------------------------------------------------+
| **Hypersensitivity Reactions**\ |
| There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in |
| patients treated with tirzepatide. In a pool of two Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), 0.1% of |
| Zepbound-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar |
| rates of severe hypersensitivity reactions were observed in Zepbound clinical trials for weight reduction and in |
| Zepbound trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and |
| discontinue use of Zepbound. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide |
| or any of the excipients in Zepbound. Use caution in patients with a history of angioedema or anaphylaxis with a |
| GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Zepbound. |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------+
+--------------------------------------------------------+
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| mobileBackgroundImagePositioning | center center |
+-----------------------------------+--------------------+
| textColor | auto |
+-----------------------------------+--------------------+
| additionalMargin | none |
+-----------------------------------+--------------------+
---
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+------------------------------------------------------------------------------------------------------------------------------------+
| IN SURMOUNT-MAINTAIN, A PHASE 3B PLACEBO-CONTROLLED TRIAL IN ADULTS WITH OBESITY18 |
+------------------------------------------------------------------------------------------------------------------------------------+
| #### Adults randomized to Zepbound met the primary endpoint at Week 112 after a 60-week open-label weight-loss period18 |
+------------------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| ### **Primary endpoint: percentage change in body weight from week 0 to week 11218,19** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| ![Mean percentage change in body weight from week 0 to week 112][image17] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Mean percentage change in body weight from week 0 to week 112][image18] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Line graph showing the efficacy estimand for the primary endpoint of percentage change in body weight from week 0 to |
| week 112. From week 0 to week 60, the open-label weight-loss period, all adults (n=441) received open-label Zepbound |
| maximum tolerated dose (MTD) (10 mg or 15 mg). At week 60 through week 112, the weight maintenance period, adults |
| were randomized to receive Zepbound MTD, have their dose reduced to Zepbound 5 mg, or switch to placebo. The week 112 |
| data are represented by treatment regimen estimand. Adults receiving Zepbound MTD (n=138) experienced a -21.9% (-54.2 |
| lb) reduction in body weight from baseline to week 112. Adults who had their dose reduced to Zepbound 5 mg (n=142) |
| experienced a -16.6% (-41.4 lb) reduction in body weight at week 112. Adults who switched to placebo (n=90) |
| experienced a -9.9% (-24.9 lb) reduction in body weight at week 112. From week 60 to week 84, rescue Zepbound was not |
| allowed. From week 84 to week 112, rescue Zepbound was allowed. The mean baseline weight was 250.9 lb. |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.18**\ |
| \ |
| The graph represents EE, the week 112 numbers indicate TRE.18\ |
| \ |
| mTRE: Average treatment effect for randomized participants based on the mITT population who stayed in the study |
| regardless of treatment discontinuation and initiation of other obesity medications. This estimand also assumes that |
| participants who had bariatric surgery or another weight-loss procedure or took rescue tirzepatide would not have |
| received any additional improvement from their randomized study treatment.\ |
| \ |
| EE: Average treatment effect in the randomized participants based on the mITT population had they remained on their |
| randomized treatment for the entire treatment duration in the study, had not taken other obesity medications, had not |
| had bariatric surgery or other weight management procedures, and assuming that participants who took rescue |
| tirzepatide would not have received any additional improvement from their randomized study treatment.\ |
| \ |
| WOCF: Data obtained after rescue tirzepatide or having bariatric surgery or other weight-loss procedures were |
| excluded and worst value observed before initiation of rescue or having bariatric surgery or other weight-loss |
| procedures was carried forward.\ |
| \ |
| aThe primary endpoint was controlled for type I error.18\ |
| bThe key secondary endpoint was controlled for type I error.18 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------+
| **Zepbound should not be used for cosmetic weight loss.**\ |
| \ |
| Studied in a randomized, phase 3b trial of adults with obesity (BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2) |
| with at least 1 weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease), |
| excluding diabetes. This study included a 2-week screening period, followed by a 60-week, open-label weight-loss period with |
| participants receiving Zepbound MTD (10 mg or 15 mg), before being randomized 3:3:2 to continue receiving Zepbound MTD (10 mg or 15 |
| mg), reduce the dose to Zepbound 5 mg, or switch to placebo from week 60 to week 112. The overall mean baseline weight was 250.9 |
| lb.18,19\ |
| \ |
| Randomization at week 60 required participants to tolerate at least the 10 mg dose during the weight-loss period and to achieve a |
| ≥5% reduction in body weight.18\ |
| \ |
| 63 out of 441 participants in the open-label weight-loss period discontinued the study drug and study. After randomization, study |
| and study drug discontinuation rates were 11 out of 140 participants assigned to continue Zepbound MTD, 13 out of 144 participants |
| allocated to Zepbound 5 mg, and 9 out of 94 participants allocated to switch to placebo.18\ |
| \ |
| Rescue Zepbound was made available starting at week 84 for participants in all 3 treatment groups if ≥50% of the initial weight |
| reduction they achieved during weeks 0-60 was regained. Randomization blinding was maintained despite receiving rescue therapy. 11 |
| participants in the Zepbound MTD group, 35 participants in the Zepbound 5 mg group, and 60 participants in the placebo group |
| received rescue Zepbound beginning at week 84.18\ |
| \ |
| Results reflect the modified treatment regimen estimand with worst observation carried forward imputation applied to data after |
| rescue.18\ |
| \ |
| mITT population includes all randomly assigned participants exposed to at least 1 dose of study intervention and excludes |
| participants who were inadvertently enrolled in the study. The primary endpoint and key secondary endpoint data are model-based |
| estimates (standard error) assessed using ANCOVA.18\ |
| \ |
| Study Limitations:\ |
| \ |
| SURMOUNT-MAINTAIN was conducted in adults with obesity who tolerated at least tirzepatide 10 mg and achieved ≥5% bodyweight |
| reduction during the open-label Weight-Loss Period; therefore, results may not be generalizable to all patients.\ |
| \ |
| A potential performance bias exists among participants who experienced weight regain following randomization.\ |
| \ |
| Initiation of intensive behavioral therapy was not permitted during the Weight Maintenance Period. |
+-------------------------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; EE=efficacy estimand; mITT=modified intent-to-treat; MTD=maximum tolerated |
| dose; TRE=treatment regimen estimand. |
+-------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Study Design](https://zepbound.lilly.com/hcp/clinical-data-weight#study-designs "View SURMOUNT-MAINTAIN Study Design") |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety-section-maintain "View SURMOUNT-MAINTAIN Safety") |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Start your patients on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Hypoglycemia**\ |
| Zepbound lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes mellitus and |
| BMI ≥27 kg/m2 (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of Zepbound-treated |
| patients versus 1.3% of placebo-treated patients. In this trial, patients taking Zepbound in combination with an |
| insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to Zepbound-treated |
| patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with |
| tirzepatide in combination with insulin. Hypoglycemia has also been associated with Zepbound and GLP-1 receptor |
| agonists in adults without type 2 diabetes mellitus. Inform patients of the risk of hypoglycemia and educate them on |
| the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting |
| Zepbound and during Zepbound treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin |
| or sulfonylurea (or other concomitantly administered insulin secretagogue). |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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---
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---
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+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-MAINTAIN, KEY SECONDARY ENDPOINT18 |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| #### Percentage maintenance of body weight reduction achieved during the open-label weight-loss period at week 112 in participants who reached a body weight plateau18\* |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
+-------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| ### **Key secondary endpoint18,20** |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| ![Percentage maintenance of body weight reduction at week 112.][image19] |
+-----------------------------------------------------------------------------------------------------------------------+
| ![Percentage maintenance of body weight reduction at week 112.][image20] |
+-----------------------------------------------------------------------------------------------------------------------+
| Show description |
| |
| Bar graph showing the key secondary endpoint of percentage maintenance of body weight reduction. Participants taking |
| Zepbound MTD (10 mg or 15 mg) (n=116) maintained 96.5% of their body weight reduction from the weight loss period. |
| Participants who reduced their dose to Zepbound 5 mg (n=118) maintained 67.9% of their body weight reduction from the |
| weight loss period. Participants who switched to placebo (n=76) maintained 42.8% of their body weight reduction from |
| the weight loss period. |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Treatment and placebo included a reduced-calorie diet and increased physical activity.18**\ |
| \ |
| Additional Key Secondary Endpoint: 77.5% of participants on Zepbound MTD (10 mg or 15 mg), 42.4% on Zepbound 5 mg, |
| and 10.4% on placebo maintained ≥80% of the body weight reduction achieved during the 60-week open-label weight-loss |
| period at Week 112 among those who reached a body weight plateau.18a\ |
| \ |
| aThe key secondary endpoints were controlled for type I error.18 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **\*Body weight plateau was defined as a <5% body weight change between week 48 and week 60.18**\ |
| \ |
| mTRE: Average treatment effect for randomized participants based on the mITT population who stayed in the study |
| regardless of treatment discontinuation and initiation of other obesity medications. This estimand also assumes that |
| participants who had bariatric surgery or another weight-loss procedure or took rescue tirzepatide would not have |
| received any additional improvement from their randomized study treatment.\ |
| \ |
| WOCF: Data obtained after rescue tirzepatide or having bariatric surgery or other weight-loss procedures were |
| excluded and worst value observed before initiation of rescue or having bariatric surgery or other weight-loss |
| procedures was carried forward. |
+-----------------------------------------------------------------------------------------------------------------------+
| ANCOVA=analysis of covariance; BMI=body mass index; mITT=modified intent-to-treat; MTD=maximum tolerated dose. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Study Design](https://zepbound.lilly.com/hcp/clinical-data-weight#study-designs "View SURMOUNT-MAINTAIN Study Design") |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Safety](https://zepbound.lilly.com/hcp/clinical-data-weight#safety-section-maintain "View SURMOUNT-MAINTAIN Safety") |
+------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+------------------------------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Start your patients on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus**\ |
| Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. |
| Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, |
| proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should |
| be monitored for progression of diabetic retinopathy. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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| mobileBackgroundImagePositioning | center center |
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| textColor | auto |
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| additionalPadding | none |
+-----------------------------------+-------------------+
| additionalMargin | none |
+-----------------------------------+-------------------+
---
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+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| ### **Safety** |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
+-------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 & SURMOUNT-2 |
+-----------------------------------------------------------------------------------------------------------------------+
| #### Adverse reactions pooled from the SURMOUNT-1 and SURMOUNT-2 trials1 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+------------------------------------+
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| Table (column2, column4, tableheader fs 24px, tabledescription fs 16px) |
+--------------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------------+
| **Adverse reactions (≥2% and greater than placebo) in Zepbound-treated adults¹** |
+--------------------------------------------------------------------------------------------------------------------------------------+
| Show description |
+--------------------------------------------------------------------------------------------------------------------------------------+
| Table of the most common adverse reactions comparing Zepbound vs placebo in the SURMOUNT-1 and SURMOUNT-2 trials. There were |
| 630, 948, 941, and 958 total adults for Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively. Nausea rates were 25% for |
| Zepbound 5 mg, 29% for Zepbound 10 mg, 28% for Zepbound 15 mg, and 8% for placebo. Diarrhea rates were 19% for Zepbound 5 mg, |
| 21% for Zepbound 10 mg, 23% for Zepbound 15 mg, and 8% for placebo. Vomiting rates were 8% for Zepbound 5 mg, 11% for Zepbound |
| 10 mg, 13% for Zepbound 15 mg, and 2% for placebo. Constipation rates were 17% for Zepbound 5 mg, 14% for Zepbound 10 mg, 11% |
| for Zepbound 15 mg, and 5% for placebo. Abdominal pain rates were 9% for Zepbound 5 mg, 9% for Zepbound 10 mg, 10% for |
| Zepbound 15 mg, and 5% for placebo. Dyspepsia rates were 9% for Zepbound 5 mg, 9% for Zepbound 10 mg, 10% for Zepbound 15 mg, |
| and 4% for placebo. Injection-site reaction rates were 6% for Zepbound 5 mg, 8% for Zepbound 10 mg, 8% for Zepbound 15 mg, and |
| 2% for placebo. Fatigue rates were 5% for Zepbound 5 mg, 6% for Zepbound 10 mg, 7% for Zepbound 15 mg, and 3% for placebo. |
| Hypersensitivity reactions rates were 5% for Zepbound 5 mg, 5% for Zepbound 10 mg, 5% for Zepbound 15 mg, and 3% for placebo. |
| Eructation rates were 4% for Zepbound 5 mg, 5% for Zepbound 10 mg, 5% for Zepbound 15 mg, and 1% for placebo. Hair loss rates |
| were 5% for Zepbound 5 mg, 4% for Zepbound 10 mg, 5% for Zepbound 15 mg, and 1% for placebo. Gastroesophageal reflux disease |
| rates were 4% for Zepbound 5 mg, 4% for Zepbound 10 mg, 5% for Zepbound 15 mg, and 2% for placebo. Flatulence rates were 3% |
| for Zepbound 5 mg, 3% for Zepbound 10 mg, 4% for Zepbound 15 mg, and 2% for placebo. Abdominal distention rates were 3% for |
| Zepbound 5 mg, 3% for Zepbound 10 mg, 4% for Zepbound 15 mg, and 2% for placebo. Dizziness rates were 4% for Zepbound 5 mg, 5% |
| for Zepbound 10 mg, 4% for Zepbound 15 mg, and 2% for placebo. Hypotension rates were 1% for Zepbound 5 mg, 1% for Zepbound 10 |
| mg, 2% for Zepbound 15 mg, and 0% for placebo. |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **ADVERSE REACTION** | row | **ZEPBOUND 5 mg | **ZEPBOUND 10 | **ZEPBOUND 15 | **PLACEBO |
| | | | (n=630)** | mg (n=948)** | mg (n=941)** | (n=958)** |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Nausea** | row, | 25% | 29% | 28% | 8% |
| | | column1text-fs-16px | | | | |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Diarrhea** | row | 19% | 21% | 23% | 8% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Vomiting** | row | 8% | 11% | 13% | 2% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Constipation** | row | 17% | 14% | 11% | 5% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Abdominal pain** | row | 9% | 9% | 10% | 5% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Dyspepsia** | row | 9% | 9% | 10% | 4% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Injection-site | row | 6% | 8% | 8% | 2% |
| | reactions** | | | | | |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Fatigue** | row | 5% | 6% | 7% | 3% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Hypersensitivity | row | 5% | 5% | 5% | 3% |
| | reactions** | | | | | |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Eructation** | row | 4% | 5% | 5% | 1% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Hair loss** | row | 5% | 4% | 5% | 1% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Gastroesophageal | row | 4% | 4% | 5% | 2% |
| | reflux disease** | | | | | |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Flatulence** | row | 3% | 3% | 4% | 2% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Abdominal distention** | row | 3% | 3% | 4% | 2% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Dizziness** | row | 4% | 5% | 4% | 2% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
| | **Hypotension** | row | 1% | 1% | 2% | 0% |
+----------------+--------------------------+---------------------+-----------------+----------------+----------------+----------------+
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| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.1 |
| |
| In a trial of adults with type 2 diabetes mellitus and BMI ≥27 kg/m2, hypoglycemia (plasma glucose <54 mg/dL) |
| was reported in 4.2% of Zepbound-treated adults versus 1.3% of placebo-treated adults.1 |
| |
| In a trial of Zepbound in adults with obesity/overweight without type 2 diabetes mellitus, there was no systematic |
| capturing of hypoglycemia, but plasma glucose <54 mg/dL was reported in 0.3% of Zepbound-treated adults versus no |
| placebo-treated adults.1 |
| |
| This table shows common adverse reactions associated with the use of Zepbound in two phase 3 placebo-controlled trials. |
| Percentages reflect the number of adult patients who reported at least 1 treatment-emergent occurrence of the adverse |
| reaction.1,2,7 |
| |
| All participants in the clinical trials received Zepbound via the single-dose pen. |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; GI=gastrointestinal; GLP-1=glucagon-like peptide-1. |
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| #### Treatment discontinuation rates pooled from the SURMOUNT-1 and SURMOUNT-2 trials1 |
+---------------------------------------------------------------------------------------------------+
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+---------------------------------------------------------------------------------------------------+
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+---------------------------------------------------------------------------------------------------+
+------------------------------------+
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| Table (column2, column4, tableheader fs 24px, tabledescription fs 16px) |
+--------------------------------------------------------------------------------------------------------------------------------+
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| **Treatment discontinuation rates1** |
+--------------------------------------------------------------------------------------------------------------------------------+
| Show description |
+--------------------------------------------------------------------------------------------------------------------------------+
| Table of discontinuation rates due to adverse reactions comparing Zepbound vs placebo in the SURMOUNT-1 and SURMOUNT-2 trials. |
| There were 630, 948, 941, and 958 total adults for Zepbound 5 mg, 10 mg, 15 mg, and placebo, respectively. Discontinuation |
| rates due to adverse reactions were 4.8% for Zepbound 5 mg, 6.3% for Zepbound 10 mg, 6.7% for Zepbound 15 mg, and 3.4% for |
| placebo. Discontinuation rates due to gastrointestinal adverse reactions were 1.9% for Zepbound 5 mg, 3.3% for Zepbound 10 mg, |
| 4\.3% for Zepbound 15 mg, and 0.5% for placebo. |
+----------------+-------------------+----------------------+-----------------+----------------+----------------+----------------+
| | **TREATMENT\ | row, | **ZEPBOUND 5 mg | **ZEPBOUND 10 | **ZEPBOUND 15 | **PLACEBO |
| | DISCONTINUATION** | column1text-fs-16px, | (n=630)** | mg (n=948)** | mg (n=941)** | (n=958)** |
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+----------------+-------------------+----------------------+-----------------+----------------+----------------+----------------+
| | **Due to ARs** | row | 4.8% | 6.3% | 6.7% | 3.4% |
+----------------+-------------------+----------------------+-----------------+----------------+----------------+----------------+
| | **Due to GI ARs** | row | 1.9% | 3.3% | 4.3% | 0.5% |
+----------------+-------------------+----------------------+-----------------+----------------+----------------+----------------+
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+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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| - The majority of adults who discontinued Zepbound due to adverse reactions did so during the first few months of treatment due to gastrointestinal adverse reactions1 |
| - The most common adverse reactions occurring more frequently with Zepbound than with placebo were GI related1 |
| - The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time1 |
| |
| Studied in adults with obesity (BMI of ≥30 kg/m2), or with overweight (BMI of ≥27 kg/m2) with at least 1 weight-related comorbidity.1 |
| |
| In Zepbound clinical trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Zepbound (5 mg 56%, 10 mg 56%, 15 mg 56%) than |
| placebo (30%).1 |
+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| AR=adverse reaction; BMI=body mass index; GI=gastrointestinal. |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Severe Gastrointestinal Adverse Reactions**\ |
| Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In a pool of two |
| Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions were reported more |
| frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates |
| of severe gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight reduction and in |
| Zepbound clinical trials for obstructive sleep apnea (OSA). Severe gastrointestinal adverse reactions have also been |
| reported postmarketing with GLP-1 receptor agonists. Zepbound is not recommended in patients with severe |
| gastroparesis. |
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| Promo Banner (left, 40a929, title fs 36px, titlestyle ringside, description fs 20px, link, sametab, select) |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| #### Adverse reactions from the SURMOUNT-5 trial |
+-----------------------------------------------------------------------------------------------------------------------+
| The overall safety profile of Zepbound in SURMOUNT-5 was similar to previously reported SURMOUNT trials.14 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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| Table (column2, tableheader fs 24px) |
+-----------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------------+
| **Adverse events that occurred in ≥5% of participants in at least one of the treatment groups14** |
+-----------------------------------------------------------------------------------------------------------------------------+
| Show description |
+-----------------------------------------------------------------------------------------------------------------------------+
| Table depicting adverse reactions that occurred in ≥5% of participants in at least one of the treatment groups: Zepbound |
| MTD (10 mg or 15 mg) (n=374) or Wegovy MTD (1.7 mg or 2.4 mg) (n=376). 43.6% of participants taking Zepbound and 44.4% |
| of participants taking Wegovy experienced nausea. 27.0% of participants taking Zepbound and 28.5% of participants taking |
| Wegovy experienced constipation. 23.5% of participants taking Zepbound and 23.4% of participants taking Wegovy |
| experienced diarrhea. 15.0% of participants taking Zepbound and 21.3% of participants taking Wegovy experienced |
| vomiting. 13.6% of participants taking Zepbound and 12.5% of participants taking Wegovy experienced COVID-19. 10.4% of |
| participants taking Zepbound and 12.2% of participants taking Wegovy experienced fatigue. 9.9% of participants taking |
| Zepbound and 7.7% of participants taking Wegovy experienced eructation. 8.6% of participants taking Zepbound and 0.3% of |
| participants taking Wegovy experienced injection site reaction. 8.6% of participants taking Zepbound and 11.4% of |
| participants taking Wegovy experienced upper respiratory tract infection. 8.3% of participants taking Zepbound and 6.1% |
| of participants taking Wegovy experienced hair loss. 7.2% of participants taking Zepbound and 6.4% of participants |
| taking Wegovy experienced abdominal distention. 7.2% of participants taking Zepbound and 7.2% of participants taking |
| Wegovy experienced headache. 6.4% of participants taking Zepbound and 6.9% of participants taking Wegovy experienced |
| abdominal pain. 6.4% of participants taking Zepbound and 4.8% of participants taking Wegovy experienced dizziness. 6.1% |
| of participants taking Zepbound and 10.6% of participants taking Wegovy experienced gastroesophageal reflux disease. |
| 5\.9% of participants taking Zepbound and 7.4% of participants taking Wegovy experienced dyspepsia. 4.5% of participants |
| taking Zepbound and 5.1% of participants taking Wegovy experienced decreased appetite. 4.5% of participants taking |
| Zepbound and 6.1% of participants taking Wegovy experienced nasopharyngitis. 2.9% of participants taking Zepbound and |
| 5\.6% of participants taking Wegovy experienced sinusitis. |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Adverse Events** | row, | **ZEPBOUND MTD 10 mg | **Wegovy MTD 1.7 mg |
| | | column1text-fs-16px, | or 15 mg (n=374)** | or 2.4 mg (n=376)** |
| | | column2text-fs-16px, | | |
| | | column3text-fs-16px | | |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Nausea** | row, | 43.6% | 44.4% |
| | | column1text-fs-16px, | | |
| | | column2text-fs-16px, | | |
| | | column3text-fs-16px | | |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Constipation** | row | 27.0% | 28.5% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Diarrhea** | row | 23.5% | 23.4% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Vomiting** | row | 15.0% | 21.3% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **COVID-19** | row | 13.6% | 12.5% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Fatigue** | row | 10.4% | 12.2% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Eructation** | row | 9.9% | 7.7% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Injection site reaction** | row | 8.6% | 0.3% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Upper respiratory tract | row | 8.6% | 11.4% |
| | infection** | | | |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Hair loss** | row | 8.3% | 6.1% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Abdominal distention** | row | 7.2% | 6.4% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Headache** | row | 7.2% | 7.2% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Abdominal pain** | row | 6.4% | 6.9% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Dizziness** | row | 6.4% | 4.8% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Gastroesophageal reflux | row | 6.1% | 10.6% |
| | disease** | | | |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Dyspepsia** | row | 5.9% | 7.4% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Decreased appetite** | row | 4.5% | 5.1% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Nasopharyngitis** | row | 4.5% | 6.1% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
| | **Sinusitis** | row | 2.9% | 5.6% |
+-----------------------+-----------------------------+-----------------------+-----------------------+-----------------------+
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| **Wegovy 7.2 mg was not evaluated in this study and has since been approved.**\ |
| \ |
| Studied in a randomized, open-label, phase 3b trial of adults who had obesity (BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2) with at least 1 weight-related comorbidity, excluding type 2 diabetes.14,21 |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; MTD=maximum tolerated dose. |
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| Promo Banner (textalign left, 40a929, title fs 36px, titlestyle ringside, description fs 16px, link, sametab, |
| select) |
+----------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------+
| #### Treatment discontinuation rates pooled from the SURMOUNT-5 trial14 |
+----------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------+
+------------------------------------+
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| Table (column2, tableheader fs 24px) |
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+----------------------------------------------------------------------------------------------------------------------+
| **Percentage of participants who discontinued treatment due to adverse event14** |
+----------------------------------------------------------------------------------------------------------------------+
| Show description |
+----------------------------------------------------------------------------------------------------------------------+
| Table depicting percentage of participants taking Zepbound MTD (10 mg or 15 mg) (n=374) or Wegovy MTD (1.7 mg or 2.4 |
| mg) (n=376) who discontinued treatment. 6.1% of participants taking Zepbound and 8.0% of participants taking Wegovy |
| discontinued due to adverse event. |
+-----------------------+-----------------------+----------------------+-----------------------+-----------------------+
| | **Treatment | row, | **ZEPBOUND MTD 10 mg | **Wegovy MTD 1.7 mg |
| | Discontinuation** | column1text-fs-16px, | or 15 mg (n=374)** | or 2.4 mg (n=376)** |
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+-----------------------+-----------------------+----------------------+-----------------------+-----------------------+
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| | to AEs** | column1text-fs-16px, | | |
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| | | column3text-fs-16px | | |
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+-----------------------------------------------------------------------------------------------------------------------+
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| AE=adverse event; MTD=maximum tolerated dose. |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Severe Gastrointestinal Adverse Reactions**\ |
| Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In a pool of two |
| Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions were reported more |
| frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates |
| of severe gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight reduction and in |
| Zepbound clinical trials for obstructive sleep apnea (OSA). Severe gastrointestinal adverse reactions have also been |
| reported postmarketing with GLP-1 receptor agonists. Zepbound is not recommended in patients with severe |
| gastroparesis. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| Promo Banner (textalign left, 40a929, title fs 36px, titlestyle ringside, description fs 16px, link, sametab, |
| select) |
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+----------------------------------------------------------------------------------------------------------------+
| #### Adverse events in SURMOUNT-MAINTAIN |
+----------------------------------------------------------------------------------------------------------------+
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| |
+----------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------+
+------------------------------------+
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| Table (column2, tableheader fs 24px) |
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+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| **Adverse events in SURMOUNT-MAINTAIN18a,b** |
+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Show description |
+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Table showing the adverse events that emerged during treatment and occurred in ≥5% of participants in any treatment group in |
| SURMOUNT-MAINTAIN. Deaths occurred in <1% of participants taking Zepbound MTD (10 mg or 15 mg) (n=441) from week 0 to week 60. From week 60 to |
| week 112, deaths occurred in 0% of patients who received Zepbound MTD (10 mg or 15 mg) (n=139), who had their dose reduced to Zepbound 5 mg |
| (n=142), or who were switched to placebo (n=91). From week 0 to week 60, participants taking Zepbound MTD (10 mg or 15 mg) (n=441) |
| experienced: nausea: 35%, vomiting: 17%, diarrhea: 24%, constipation: 31%, eructation: 8%, dyspepsia: 7%, gastroesophageal reflux disease: 7%, |
| abdominal pain: 6%, abdominal distension: 5%, upper respiratory tract infection: 7%, COVID-19: 7%, influenza: 5%, sinusitis: 3%, urinary tract |
| infection: 3%, injection site reaction: 9%, fatigue: 10%, headache: 9%, dizziness: 7%, decreased appetite: 5%, and alopecia: 9%. Participants |
| taking Zepbound MTD (10 mg or 15 mg) (n=139) experienced from week 60 to week 112: nausea: 6%, vomiting: 6%, diarrhea: 7%, constipation: 1%, |
| eructation: 3%, dyspepsia: 2%, gastroesophageal reflux disease: 1%, abdominal pain: 1%, abdominal distension: 3%, upper respiratory tract |
| infection: 1%, COVID-19: 1%, influenza: 4%, sinusitis: 5%, urinary tract infection: 5%, injection site reaction: 6%, fatigue: 1%, headache: |
| 2%, dizziness: 1%, decreased appetite: 0%, and alopecia: 1%. Participants who had their dose reduced to Zepbound 5 mg (n=142) experienced from |
| week 60 to week 112: nausea: 4%, vomiting: 1%, diarrhea: 5%, constipation: 4%, eructation: 1%, dyspepsia: 1%, gastroesophageal reflux disease: |
| 1%, abdominal pain: 1%, abdominal distension: 1%, upper respiratory tract infection: 4%, COVID-19: 3%, influenza: 1%, sinusitis: 5%, urinary |
| tract infection: 1%, injection site reaction: 2%, fatigue: 0%, headache: 4%, dizziness: 1%, decreased appetite: 0%, and alopecia: 0%. |
| Participants who were switched to placebo (n=91) experienced from week 60 to week 112: nausea: 2%, vomiting: 0%, diarrhea: 1%, constipation: |
| 4%, eructation: 0%, dyspepsia: 0%, gastroesophageal reflux disease: 1%, abdominal pain: 0%, abdominal distension: 1%, upper respiratory tract |
| infection: 2%, COVID-19: 0%, influenza: 4%, sinusitis: 0%, urinary tract infection: 0%, injection site reaction: 0%, fatigue: 0%, headache: |
| 3%, dizziness: 0%, decreased appetite: 0%, and alopecia: 0%. |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | | row, | WEEK 0 TO WEEK | WEEK 60 TO WEEK 112 | WEEK 60 TO WEEK | WEEK 60 TO WEEK 112 |
| | | column2text-fs-16px, | 60 **ZEPBOUND | **ZEPBOUND MTD (10 | 112 **REDUCED TO | **SWITCHED TO PLACEBO** (n=91) |
| | | column3text-fs-16px, | MTD (10 mg OR 15 | mg OR 15 mg)** (n=139) | ZEPBOUND 5 mg** (n=142) | |
| | | column4text-fs-16px | mg)** (n=441) | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Deaths** | row, | <1% | 0% | 0% | 0% |
| | | column1text-fs-16px, | | | | |
| | | column2text-fs-16px, | | | | |
| | | column3text-fs-16px, | | | | |
| | | column4text-fs-16px, | | | | |
| | | column5text-fs-16px | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Adverse Events | row, | | | | |
| | That Emerged | column1text-fs-16px, | | | | |
| | During Treatment | column2text-fs-16px | | | | |
| | and Occurred in | | | | | |
| | ≥5% of | | | | | |
| | Participants in | | | | | |
| | Any Treatment | | | | | |
| | Group** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Nausea** | row, | 35% | 6% | 4% | 2% |
| | | column1text-fs-16px, | | | | |
| | | column2text-fs-16px, | | | | |
| | | column3text-fs-16px, | | | | |
| | | column4text-fs-16px, | | | | |
| | | column5text-fs-16px | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Vomiting** | row | 17% | 6% | 1% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Diarrhea** | row | 24% | 7% | 5% | 1% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Constipation** | row | 31% | 1% | 4% | 4% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Eructation** | row | 8% | 3% | 1% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Dyspepsia** | row | 7% | 2% | 1% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Gastroesophageal | row | 7% | 1% | 1% | 1% |
| | reflux disease** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Abdominal Pain** | row | 6% | 1% | 1% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Abdominal | row | 5% | 3% | 1% | 1% |
| | distension** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Upper | row | 7% | 1% | 4% | 2% |
| | respiratory tract | | | | | |
| | infection** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **COVID-19** | row | 7% | 1% | 3% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Influenza** | row | 5% | 4% | 1% | 4% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Sinusitis** | row | 3% | 5% | 5% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Urinary tract | row | 3% | 5% | 1% | 0% |
| | infection** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Injection site | row | 9% | 6% | 2% | 0% |
| | reaction** | | | | | |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Fatigue** | row | 10% | 1% | 0% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Headache** | row | 9% | 2% | 4% | 3% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Dizziness** | row | 7% | 1% | 1% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Decreased appetite** | row | 5% | 0% | 0% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Alopecia** | row | 9% | 1% | 0% | 0% |
+----------------+------------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
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| aDuring the weight-loss period, participants initiated tirzepatide at 2.5 mg once weekly and titrated in |
| 2\.5 mg increments every 4 weeks until a maximum tolerated dose of 10 mg or 15 mg was achieved. Data obtained during |
| the weight-maintenance period after rescue Zepbound were excluded.18\ |
| bThe total number of participants in the open-label weight-loss period includes anyone who got treatment, |
| whereas the total number of participants for the double-blind weight maintenance period includes anyone who received |
| treatment during the double-blind period only.18 |
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| **Treatment discontinuation rates in the SURMOUNT-MAINTAIN trial18** |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Show description |
+------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Table of discontinuation rates due to adverse events in the SURMOUNT-MAINTAIN trial. From week 0 to week 60, 5% of participants taking |
| Zepbound MTD (10 mg or 15 mg) (n=441) discontinued treatment due to adverse events or death and 2% discontinued treatment due to |
| gastrointestinal adverse events. From week 60 to week 112, 0% of participants taking Zepbound MTD (10 mg or 15 mg) (n=139) discontinued |
| treatment due to adverse events or death and 0% discontinued treatment due to gastrointestinal adverse events. From week 60 to week 112, 1% |
| of participants who reduced their dose to Zepbound 5 mg (n=142) discontinued treatment due to adverse events or death and 0% discontinued |
| treatment due to gastrointestinal adverse events. From week 60 to week 112, 0% of participants who switched to placebo (n=91) discontinued |
| treatment due to adverse events or death and 0% discontinued treatment due to gastrointestinal adverse events. |
+----------------+-------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **TREATMENT | row, | WEEK 0 TO WEEK | WEEK 60 TO WEEK 112 | WEEK 60 TO WEEK | WEEK 60 TO WEEK 112 |
| | DISCONTINUATION** | column1text-fs-16px, | 60 **ZEPBOUND | **ZEPBOUND MTD (10 | 112 **REDUCED TO | **SWITCHED TO PLACEBO** (n=91) |
| | | column2text-fs-16px, | MTD (10 mg OR 15 | mg OR 15 mg)** (n=139) | ZEPBOUND 5 mg** (n=142) | |
| | | column3text-fs-16px, | mg)** (n=441) | | | |
| | | column4text-fs-16px, | | | | |
| | | column5text-fs-16px | | | | |
+----------------+-------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Due to AEs or | row, | 5% | 0% | 1% | 0% |
| | death** | column1text-fs-16px, | | | | |
| | | column2text-fs-16px, | | | | |
| | | column3text-fs-16px, | | | | |
| | | column4text-fs-16px, | | | | |
| | | column5text-fs-16px | | | | |
+----------------+-------------------+----------------------+------------------+------------------------+-------------------------+--------------------------------+
| | **Due to GI AEs** | row, | 2% | 0% | 0% | 0% |
| | | column1text-fs-16px, | | | | |
| | | column2text-fs-16px, | | | | |
| | | column3text-fs-16px, | | | | |
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+-------------------------------------------------------------------------------------------------------------------------+
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| The majority of adults who discontinued Zepbound due to adverse events did so during the initial 60-week, open-label |
| weight-loss period.18\ |
| \ |
| The most common adverse events occurring more frequently with Zepbound than with placebo were GI related.18\ |
| \ |
| The majority of reports of nausea, vomiting, and/or diarrhea occurred during the initial 60-week, open-label |
| weight-loss period and decreased over time.18 |
+-------------------------------------------------------------------------------------------------------------------------+
| MTD=maximum tolerated dose. |
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Severe Gastrointestinal Adverse Reactions**\ |
| Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In a pool of two |
| Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions were reported more |
| frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates |
| of severe gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight reduction and in |
| Zepbound clinical trials for obstructive sleep apnea (OSA). Severe gastrointestinal adverse reactions have also been |
| reported postmarketing with GLP-1 receptor agonists. Zepbound is not recommended in patients with severe |
| gastroparesis. |
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-1 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-1 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-2 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-2 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-3 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-3 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-4 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-4 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-5 Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-5 Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [View SURMOUNT-MAINTAIN Study Design](/hcp/clinical-data-weight#study-designs "View SURMOUNT-MAINTAIN Study Design") |
+-----------------------------------------------------------------------------------------------------------------------+
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| Section Metadata |
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+--------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
| ### **Study Designs** |
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+--------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-1 |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-1 was a 72-week, double-blind, placebo-controlled, phase 3 trial that randomized 2539 adult patients with a |
| body mass index (BMI) of ≥30 kg/m2 or ≥27 kg/m2 and at least 1 weight-related comorbid |
| condition (study excluded patients with type I diabetes or type 2 diabetes), to receive once-weekly subcutaneous |
| Zepbound 5 mg, 10 mg, 15 mg, or placebo (1:1:1:1 ratio), including a 20-week dose-escalation period. Treatment was an |
| adjunct to a reduced-calorie diet and increased physical activity.\* Mean baseline body weight for Zepbound 5 mg was |
| 226\.8 lb, for Zepbound 10 mg 233.3 lb, for Zepbound 15 mg 232.8 lb, and for placebo 231.0 lb.1-3 |
| |
| Coprimary endpoints were to demonstrate that Zepbound 10 mg and/or 15 mg are superior to placebo for mean percent |
| change in body weight from baseline and percentage of study participants who achieved ≥5% body weight reduction at 72 |
| weeks.1,2 |
| |
| Secondary endpoints were assessed at 72 weeks: superiority of Zepbound 5 mg to placebo for mean percent change in |
| body weight and percentage of participants who achieved ≥5% body weight reduction; superiority of Zepbound 10 mg |
| and/or 15 mg to placebo for percentage of participants who achieved ≥10% body weight reduction, ≥15% body weight |
| reduction, and/or ≥20% body weight reduction.2 |
| |
| \*Reduced-calorie diet (approximately 500 kcal/day deficit) and increased physical activity (recommended to a minimum |
| of 150 min/week).1 |
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+--------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| ![Shield with exclamation point inside][image5] |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| **Select Important Safety Information** |
| |
| **Pulmonary Aspiration During General Anesthesia or Deep Sedation**\ |
| Zepbound delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients |
| receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep |
| sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. |
| Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general |
| anesthesia or deep sedation in patients taking Zepbound, including whether modifying preoperative fasting |
| recommendations or temporarily discontinuing Zepbound could reduce the incidence of retained gastric contents. |
| Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking |
| Zepbound. |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------+
| Section Metadata |
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---
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+----------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-2 |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
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+--------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-2 was a 72-week, double-blind, placebo-controlled, phase 3 trial that randomized 938 adult patients with a body |
| mass index (BMI) of ≥27 kg/m2 and type 2 diabetes to receive once-weekly subcutaneous Zepbound 10 mg, 15 mg, or |
| placebo (1:1:1 ratio), including a 20-week dose-escalation period. Treatment with Zepbound or placebo was an adjunct to a |
| reduced-calorie diet and increased physical activity.† Patients included in the trial were treated with diet and |
| exercise alone or with any oral anti-hyperglycemic agent except DPP-4 inhibitors or GLP-1 receptor agonists. Patients taking |
| injectable therapies for type 2 diabetes were excluded from the study. Mean baseline body weight was 222.4 lb for Zepbound |
| 10 mg, 219.6 lb for Zepbound 15 mg, and 224.2 lb for placebo.1,5,7 |
| |
| Coprimary endpoints were to demonstrate that Zepbound 10 mg and/or 15 mg are superior to placebo for mean percent change in |
| body weight from baseline and percentage of study participants who achieved ≥5% body weight reduction at 72 weeks.1 |
| |
| Some key secondary endpoints assessed at 72 weeks were superiority of Zepbound 10 mg and/or 15 mg to placebo for percentage |
| of participants who achieved ≥10%, ≥15%, and/or ≥20% body weight reduction; mean change in A1C (%); percentage of |
| participants who achieved A1C <7%; and mean change in fasting glucose.1,7 |
| |
| †Reduced-calorie diet (approximately 500 kcal/day deficit) and increased physical activity counseling |
| (recommended to a minimum of 150 min/week).1 |
+--------------------------------------------------------------------------------------------------------------------------------+
| DPP-4=dipeptidyl peptidase-4; GLP-1=glucagon-like peptide-1. |
+--------------------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------------------+
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+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-3 |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-3 was an 84-week, placebo-controlled, phase 3 trial that enrolled 806 patients with a body mass index (BMI) of |
| ≥30 kg/m2, or ≥27 kg/m2 and at least 1 weight-related comorbid condition (excluding type 2 |
| diabetes). Following a 12-week lead-in period that included intensive lifestyle intervention‡, participants |
| achieving ≥5% weight reduction (n=579) were randomized 1:1 to either Zepbound maximum tolerated dose (10 mg or 15 mg) or |
| to placebo once-weekly for 72 weeks. Treatment in both groups included a reduced-calorie diet and increased physical |
| activity.1¶ |
| |
| Coprimary endpoints were mean percentage change in weight from randomization (week 0) to week 72 and percentage of |
| participants achieving weight reduction ≥5% from randomization (week 0) to week 72.1 |
| |
| ‡Intensive lifestyle intervention during the lead-in period included a diet of approximately 1200 kcal/day for |
| women and 1500 kcal/day for men and at least 150 minutes of moderate intensity exercise per week. |
| |
| ¶During the randomized treatment period, exercise requirements were 150 minutes of moderate activity per week |
| and maintenance of daily energy intake to 500 kcal below individual energy requirements as calculated by the Food and |
| Agriculture Organization of the United Nations/World Health Organization/United Nations University (FAO/WHO/UNU) estimates |
| of human energy requirements, using a sedentary physical activity level (PAL) of 1.3.22 |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-4 |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-4 was an 88-week phase 3 withdrawal trial that enrolled 783 adults with a body mass index (BMI) ≥30 kg/m2, or with a BMI 27 to <30 kg/m2 with at least one |
| weight-related comorbid condition (excluding type 2 diabetes). All participants received Zepbound once weekly during the 36-week lead-in period, which included a 20-week dose escalation |
| period. At week 36, 670 participants were randomized 1:1 to a maximum tolerated dose of Zepbound (10 mg or 15 mg) or placebo once weekly for 52 weeks. Treatment throughout the 88-week period |
| included a reduced-calorie diet (approximately 500 kcal/day deficit) and increased physical activity (recommended minimum of 150 min/week) for both arms of the study.1\ |
| \ |
| Mean baseline (week 0) weight for all participants was 236.6 lbs.12 The primary endpoint was mean percent change in body weight from randomization (week 36) to week 88.1 |
| Some key secondary endpoints\* included mean change in body weight (kg) from week 36 to week 88, mean change in waist circumference from week 36 to week 88, percentage of participants |
| maintaining at least 80% of body weight lost during the 36-week open-label lead-in period at week 88, percentage of patients achieving body weight reduction (≥5%, ≥10%, ≥15%, ≥20%) from week |
| 0 to week 88, and time during the double-blind treatment period (week 36 to 88) to first occurrence of participants returning to >95% baseline body weight for those who lost at least 5% body |
| weight during the lead-in period.13\ |
| \ |
| \*Controlled for type I error and tested for superiority. |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-5 |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
| |
+--------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-5 was a 72-week, phase 3b, parallel-design, open-label, randomized active-controlled study that evaluated the |
| safety and efficacy of Zepbound 15 mg or MTD (10 mg or 15 mg) compared with Wegovy (semaglutide) injection 2.4 mg or MTD |
| (1.7 mg or 2.4 mg) in adults with obesity (BMI ≥30 kg/m2), or with overweight (BMI ≥27 kg/m2) with |
| at least 1 weight-related comorbidity, excluding type 2 diabetes. Treatment was an adjunct to a reduced-calorie diet and |
| increased physical activity. The study included a 2-week screening period. Mean baseline weight was 248.4 lb for Zepbound |
| 15 mg or MTD (10 mg or 15 mg) and 250.0 lb for Wegovy 2.4 mg or MTD (1.7 mg or 2.4 mg).14,16\ |
| \ |
| Primary endpoint was to demonstrate that Zepbound 15 mg or MTD (10 mg or 15 mg) is superior to Wegovy 2.4 mg or MTD (1.7 |
| mg or 2.4 mg) for mean percent change in body weight from baseline at 72 weeks.14\ |
| \ |
| Key secondary endpoints were assessed at 72 weeks to demonstrate that Zepbound 15 mg or MTD (10 mg or 15 mg) is superior |
| to Wegovy 2.4 mg or MTD (1.7 mg or 2.4 mg) for14: |
| |
| - Body weight reductions of ≥10%, ≥15%, ≥20%, and ≥25% from baseline |
| - Change in waist circumference (cm) from baseline |
| |
| Primary and key secondary endpoints were controlled for multiplicity.14\ |
| \ |
| **Wegovy 7.2 mg was not evaluated in this study and has since been approved.**\ |
| \ |
| Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity.1\ |
| \ |
| Wegovy® is a registered trademark of Novo Nordisk A/S. |
+----------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; MTD=maximum tolerated dose. |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| #### SURMOUNT-MAINTAIN |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
+-----------------------------------------------------------------------------------------------------------------------------------+
| SURMOUNT-MAINTAIN was a randomized, double-blind, parallel-group, placebo-controlled, phase 3b, 112-week trial in adults with |
| obesity (BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2) with at least 1 weight-related comorbidity |
| (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease), excluding diabetes. After a 2-week screening |
| period, then a 60-week, open-label weight-loss period where patients were treated with TZP MTD, eligible participants who lost |
| ≥5% of their body weight and tolerated at least the 10 mg dose were randomized (3:3:2) to continue once-weekly treatment with |
| Zepbound MTD (10 mg or 15 mg), to reduce the dose to 5 mg, or to switch to placebo for an additional 52 weeks. The mean baseline |
| weight was 250.9 lb.18,19\ |
| \ |
| Rescue Zepbound was made available starting at week 84 for participants in all 3 treatment groups if ≥50% of the initial weight |
| reduction they achieved during weeks 0-60 was regained. Randomization blinding was maintained despite receiving rescue therapy. |
| 11 participants in the Zepbound MTD group, 35 participants in the Zepbound 5 mg group, and 60 participants in the placebo group |
| received rescue Zepbound beginning at week 84.18\ |
| \ |
| All participants received lifestyle intervention, including a reduced-calorie diet and increased physical activity.18\ |
| \ |
| Primary endpoint18: |
| |
| - Percentage change in body weight from baseline (week 0) to week 112 |
| |
| Select key secondary endpoints18: |
| |
| - Percentage maintenance of body weight reduction achieved during the weight-loss period (week 0 to week 60) at week 112 among |
| participants who reached a body weight plateau (defined as <5% body weight change between week 48 and week 60) |
| - Percentage of participants maintaining ≥80% of the body weight reduction achieved during the weight-loss period (week 0 to week |
| 60) at week 112 among participants who reached a body weight plateau |
| - Change in absolute body weight from baseline to week 112, kg |
| |
| Primary and key secondary endpoints were controlled for type I error.18 |
+-----------------------------------------------------------------------------------------------------------------------------------+
| BMI=body mass index; MTD=maximum tolerated dose. |
+-----------------------------------------------------------------------------------------------------------------------------------+
| |
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| |
+-----------------------------------------------------------------------------------------------------------------------------------+
| |
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+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| [Start your patients on Zepbound](/hcp/getting-patients-started "Get a patient started on Zepbound") |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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+-------------------------------------------------------------------------------------------------------------------+
| SUPPORTING YOUR PATIENT'S JOURNEY |
+-------------------------------------------------------------------------------------------------------------------+
| **Helpful resources for you.** |
+-------------------------------------------------------------------------------------------------------------------+
| Discover how you can help your patients by completing prior authorization, ordering a demo kit, or learning about |
| savings options. |
+-------------------------------------------------------------------------------------------------------------------+
| [Explore all resources](/hcp/getting-patients-started "Explore all resources") |
+-------------------------------------------------------------------------------------------------------------------+
| |
+-------------------------------------------------------------------------------------------------------------------+
+-------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| AUTHORIZATION GUIDE |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
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| |
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Get the Prior Authorization Guide |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| A helpful guide on how to complete a prior authorization. |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| [Get the guide](https://delivery-p137454-e1438138.adobeaemcloud.com/adobe/assets/urn:aaid:aem:f466b95c-bba8-493c-a123-eb630617fd08/renditions/original/as/Zepbound-HCP-Prior_Authorization_Resource_Guide-Digital-2025.pdf?assetname=Zepbound-HCP-Prior_Authorization_Resource_Guide-Digital-2025.pdf "Read the prior authorization guide to learn more about the appeals process with healthcare providers") |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------------+
| SAVINGS CARD |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------------+
+-----------------------------------------------------------+
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+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
| |
+-----------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
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+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Share the Zepbound Savings Card for the Single-Dose Pen |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Download a savings card for the single-dose Pen for your eligible, commercially insured patients with Zepbound coverage.\ |
| \ |
| **Governmental beneficiaries excluded, terms and conditions apply.** [Review full terms and conditions](/savings#terms-and-conditions "Terms and Conditions") |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| [Learn more](/hcp/coverage-savings "Learn more about the Zepbound savings card") |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
| |
+---------------------------------------------------------------------------------------------------------------------------------------------------------------+
+---------------------------------------------------------+
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| 2.5 MG IS A STARTING DOSE AND IS NOT AN APPROVED MAINTENANCE DOSE |
| |
| Zepbound® KwikPen® for single-patient-use. |
+-------------------------------------------------------------------------------------------------------------------+
| **Help your patient with affordability options** |
+-------------------------------------------------------------------------------------------------------------------+
| Check out Zepbound’s Savings and Support page to learn more about cost, insurance coverage, and more. |
+-------------------------------------------------------------------------------------------------------------------+
| [Explore savings and support](/hcp/coverage-savings "explore savings and support") |
+-------------------------------------------------------------------------------------------------------------------+
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| **References** |
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| 1. Zepbound. Prescribing Information. Lilly USA, LLC. |
| 2. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. *N Engl J Med*. 2022;387(3)(Incl suppl mat):205-216. doi:10.1056/NEJMoa2206038 |
| 3. Data on File. DOF-ZP-US-0001. Lilly USA, LLC. |
| 4. Data on File. DOF-ZP-US-0006. Lilly USA, LLC. |
| 5. Data on File. DOF-ZP-US-0005. Lilly USA, LLC. |
| 6. Data On File. DOF-ZP-US-0009. Lilly USA, LLC. |
| 7. Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, |
| placebo-controlled, phase 3 trial. *Lancet*. 2023;402(10402):613-626. doi:10.1016/S0140-6736(23)01200-X |
| 8. Data on File. DOF-ZP-US-0060. Lilly USA, LLC. |
| 9. Data On File. DOF-ZP-US-0004. Lilly USA, LLC. |
| 10. Data on File. DOF-ZP-US-0019. Lilly USA, LLC. |
| 11. Data on File. DOF-ZP-US-0022. Lilly USA, LLC. |
| 12. Data on File. DOF-ZP-US-0024. Lilly USA, LLC. |
| 13. Aronne LJ, Sattar N, Horn DB, et al. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. *JAMA*. 2024;331(1):38-48 (incl suppl 2). doi:10.1001/jama.2023.24945 |
| 14. Aronne LJ, Bade Horn D, le Roux CW, et al. Tirzepatide as compared with semaglutide for the treatment of obesity. *N Engl J Med*. 2025;393(1)(Incl suppl append):26-36. doi:10.1056/NEJMoa2416394 |
| 15. Data on File. DOF-ZP-US-0036. Lilly USA, LLC. |
| 16. Data on File. DOF-ZP-US-0035. Lilly USA, LLC. |
| 17. Data on File. DOF-ZP-US-0054. Lilly USA, LLC. |
| 18. Horn DB, Aronne LJ, Wharton S, et al. Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, |
| placebo-controlled trial. *Lancet*. 2026;Epub(Incl suppl append). doi:10.1016/S0140-6736(26)00656-2 |
| 19. Data on File. CREF-1379. Lilly USA, LLC. |
| 20. Data on File. CREF-1645. Lilly USA, LLC. |
| 21. A study of tirzepatide (LY3298176) in participants with obesity or overweight with weight related comorbidities (SURMOUNT-5). ClinicalTrials.gov identifier: NCT05822830. Updated December 11, |
| 2024\. Accessed March 27, 2025. https\://clinicaltrials.gov/ct2/show/NCT05822830 |
| 22. Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. *Nat Med*. 2023;29(11)(suppl mat):2909-2918. doi:10.1038/s41591-023-02597-w |
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| | | | ctatarget-sametab, | [(1-800-545-5979)](tel:1-800-545-5979) to contact Lilly Support Services | | |
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| CMAT-22248 08/2026 **[© Lilly USA, LLC 2026. All rights reserved.](https://lillyhub.com/legal/lillyusa/english/copyright.html "Copyright")** |
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| title | Clinical Data, Safety & Study Design \| Zepbound® (tirzepatide) |
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| published-time | 2026-08-14T19:25:06.948Z |
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| description | Learn more about Zepbound® (tirzepatide) weight reduction (WR) efficacy and safety clinical data in adults |
| | with obesity and excess weight. |
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| canonical | https\://zepbound.lilly.com/hcp/clinical-data-weight |
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| footer\_mmn | CMAT-02859 |
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| footer\_mmn\_date | 1/2026 |
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| modified-time | 2026-08-11T19:10:16.148Z |
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---
## IMPORTANT SAFETY INFORMATION FOR ZEPBOUND® (tirzepatide) INJECTION
[ WARNING: RISK OF THYROID C-CELL TUMORS
In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Zepbound.
]
CONTRAINDICATIONS
Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with tirzepatide.
Risk of Thyroid C-cell Tumors
Counsel patients regarding the potential risk for MTC with the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Zepbound. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Severe Gastrointestinal Adverse Reactions
Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In a pool of two Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates of severe gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight reduction and in Zepbound clinical trials for obstructive sleep apnea (OSA). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Zepbound is not recommended in patients with severe gastroparesis.
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP‑1 receptor agonists, or Zepbound. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Zepbound that could lead to volume depletion, especially during dosage initiation and escalation of Zepbound.
Acute Gallbladder Disease
Treatment with Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two clinical trials of Zepbound (SURMOUNT-1 and SURMOUNT-2), cholelithiasis was reported in 1.1% of Zepbound-treated patients and 1.0% of placebo-treated patients, cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in Zepbound clinical trials for weight reduction and in Zepbound trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP‑1 receptor agonists, or Zepbound. After initiation of Zepbound, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue Zepbound and initiate appropriate management.
Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In a pool of two Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2), 0.1% of Zepbound-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were observed in Zepbound clinical trials for weight reduction and in Zepbound trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of Zepbound. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in Zepbound. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Zepbound.
Hypoglycemia
Zepbound lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m2 (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of Zepbound-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking Zepbound in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to Zepbound-treated patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin. Hypoglycemia has also been associated with Zepbound and GLP-1 receptor agonists in adults without type 2 diabetes mellitus. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting Zepbound and during Zepbound treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Pulmonary Aspiration During General Anesthesia or Deep Sedation
Zepbound delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking Zepbound, including whether modifying preoperative fasting recommendations or temporarily discontinuing Zepbound could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Zepbound.
Never Share a Zepbound® KwikPen® Between Patients
Never share Zepbound KwikPen between patients, even if the pen needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
Most Common Adverse Reactions
The most common adverse reactions reported in ≥5% of patients treated with Zepbound are nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
Drug Interactions
Zepbound lowers blood glucose. When initiating Zepbound, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia. Zepbound delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Zepbound. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with Zepbound.
Pregnancy
Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue Zepbound when a pregnancy is recognized. Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Zepbound (tirzepatide) during pregnancy.
Pregnant patients exposed to Zepbound and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
Lactation
In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose. There are no available data on the effects of tirzepatide on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zepbound and any potential adverse effects on the breastfed infant from Zepbound or from the underlying maternal condition.
Females and Males of Reproductive Potential
Use of Zepbound may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation with Zepbound and for 4 weeks after each dose escalation.
Pediatric Use
The safety and effectiveness of Zepbound have not been established in pediatric patients.
Zepbound is available a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg injection.
Please see accompanying Prescribing Information, Including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.
Please see Instructions for Use.
ZP HCP ISI 25FEB2026
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Zepbound®, its delivery device base, and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Zepbound is available by prescription only.
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## INDICATIONS
Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity:
to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
to treat moderate-to-severe-obstructive sleep apnea (OSA) in adults with obesity.
Limitations of Use:
Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.