A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Purpose
This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 visits).
Conditions
- Obesity
- Overweight
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease - History of at least one unsuccessful dietary effort to lose body weight
Exclusion Criteria
- Diabetes mellitus - Change in body weight greater than 5 kg within 3 months prior to starting study - Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity - History of pancreatitis - Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) - History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years - Any lifetime history of a suicide attempt
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 Tirzepatide |
Tirzepatide administered subcutaneously (SC) |
|
|
Placebo Comparator Placebo |
Placebo administered SC |
|
More Details
- Status
- Completed
- Sponsor
- Eli Lilly and Company