A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.

Detailed Description
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All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.

Official Title
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A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW) Exclusion Criteria: Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma. Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening. Have a history of chronic or acute pancreatitis Have any of the following cardiovascular conditions within 3 months prior to week 0. Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF) family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years Any lifetime history of a suicide attempt

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3b
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide 5 milligram (mg)<br>Participants will receive tirzepatide subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Maximum Tolerated Dose<br>Participants will receive tirzepatide SC. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo<br>Participants will receive placebo. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period | Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau. | Week 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period | Assessment of (yes/no) of maintaining ≥80% of the BW reduction achieved during the 60-week weight loss period will be measured in participants who have reached a BW plateau. | Week 112 | 
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization | Assessment of (yes/no) of maintaining ≥15% BW reduction for participants who have already lost ≥15% BW at randomization will be measured in participants who have reached a BW plateau. | Week 112 | 
| Percent Change from Baseline in Body Weight |  | Baseline (Week 0), Week 112 | 
| Change from Randomization in Body Weight |  | Week 60, Week 112 | 
| Percent Change from Randomization in Body Weight |  | Week 60, Week 112 | 
| Change from Randomization in Waist Circumference |  | Week 60, Week 112 | 
| Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period |  | Week 84 |