A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Purpose
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.
Conditions
- Obesity
- Cardiovascular Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Retatrutide Dose 1 |
Participants will receive retatrutide subcutaneously (SC). |
|
|
Experimental Retatrutide Dose 2 |
Participants will receive retatrutide SC. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05882045
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company