Obesity
Conditions
Brief summary
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 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)
Intervention model description
Phase 3b
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 Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes * 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) * 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 * Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Week 0, Week 116 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Waist Circumference | Week 0, Week 116 |
| Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116 | Week 0, Week 80, Week 116 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) | Week 0, Week 116 |
Countries
Canada, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed