NCT06662383
Active, not recruiting
Phase 3
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity
Overview
- Phase
- Phase 3
- Intervention
- Retatrutide
- Conditions
- Obesity
- Sponsor
- Eli Lilly and Company
- Enrollment
- 800
- Locations
- 122
- Primary Endpoint
- Percent Change from Baseline in Body Weight
- Status
- Active, not recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
Exclusion Criteria
- •Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening.
- •Have a prior or planned surgical treatment for obesity.
- •Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- •Have had within the past 90 days before screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •coronary revascularization
- •hospitalization for unstable angina, or
Arms & Interventions
Retatrutide
Participants will receive retatrutide administered subcutaneously (SC)
Intervention: Retatrutide
Tirzepatide
Participants will receive tirzepatide administered SC
Intervention: Tirzepatide
Outcomes
Primary Outcomes
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 80
Secondary Outcomes
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 80)
- Change from Baseline in Waist Circumference(Baseline, Week 80)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 80)
- Percent Change from Baseline in Triglycerides(Baseline, Week 80)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 80)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 80)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 80)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 80)
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)(Baseline, Week 80)
Study Sites (122)
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