A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
- Registration Number
- NCT06662383
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
-
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
- hospitalization due to congestive heart failure.
-
Have New York Heart Association Functional Classification Class IV congestive heart failure.
-
Have a history of chronic or acute pancreatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive tirzepatide administered SC Retatrutide Retatrutide Participants will receive retatrutide administered subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 80
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (65)
Medical Advancement Centers of Arizona
🇺🇸Tempe, Arizona, United States
Mary & Dick Allen Diabetes Center
🇺🇸Newport Beach, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
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