Cardiovascular Diseases, Obesity
Conditions
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.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 80 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score | 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. |
Countries
Argentina, Australia, Canada, Hungary, Mexico, Poland, Puerto Rico, Slovakia, Spain, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed