A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Purpose
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Conditions
- Overweight
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: - Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease - Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Exclusion Criteria
- Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma. - Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening - Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening. - Have a history of chronic or acute pancreatitis - Have any of the following cardiovascular conditions within 3 months prior to week 0. - Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF) - 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
- Intervention Model Description
- 3b
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tirzepatide 5 milligram (mg) |
Participants will receive tirzepatide subcutaneously (SC). |
|
|
Experimental Tirzepatide Maximum Tolerated Dose |
Participants will receive tirzepatide SC. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Detailed Description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.