A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
- Conditions
- ObesityCardiovascular Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05882045
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1800
-
Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
-
Have established cardiovascular (CV) disease with at least 1 of the following:
- prior myocardial infarction
- prior ischemic or hemorrhagic stroke, or
- symptomatic peripheral arterial disease
-
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
- Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment of obesity.
- Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
- Have Type 1 diabetes.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 1 Retatrutide Participants will receive retatrutide subcutaneously (SC). Retatrutide Dose 2 Retatrutide Participants will receive retatrutide SC. Placebo Placebo Participants will receive placebo.
- 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 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC) Baseline to Week 80 AUC is presented as a single average measure of AUC across the study duration.
Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 80 Percent Change from Baseline in Fasting Insulin 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 Hemoglobin A1c (HbA1c) Baseline, Week 80 Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score Baseline, Week 80
Related Research Topics
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Trial Locations
- Locations (165)
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Valley Research
🇺🇸Fresno, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Los Alamitos, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Van Nuys, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Scroll for more (155 remaining)Central Phoenix Medical Clinic🇺🇸Phoenix, Arizona, United States