Obesity
Conditions
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.
Interventions
DRUGRetatrutide
Administered SC
DRUGTirzepatide
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 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 80 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Argentina, Germany, Poland, Puerto Rico, 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