A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Study Overview
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Brief Summary
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The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Official Title
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A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease Have a history of at least 1 unsuccessful dietary effort to lose body weight Exclusion Criteria: Diabetes mellitus Change in body weight greater than 5 kg within 3 months prior to starting study Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity History of pancreatitis 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

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: Phase 3b
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide<br>Participants will receive tirzepatide subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Active Comparator: Semaglutide<br>Participants will receive semaglutide SC. | Drug: Semaglutide<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Body Weight |  | Baseline, Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction |  | Week 72 | 
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction |  | Week 72 | 
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction |  | Week 72 | 
| Percentage of Participants Who Achieve ≥25% Body Weight Reduction |  | Week 72 | 
| Change from Baseline in Waist Circumference in Centimeter (cm) |  | Baseline, Week 72 | 
| Percentage of Participants Who Achieve ≥30% Body Weight Reduction |  | Week 72 | 
| Change from Baseline in Body Mass Index (BMI) |  | Baseline, Week 72 | 
| Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg |  | Baseline, Week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism and Nutrition, Disorder, Prediabetes, Diet, Exercise