Overview

A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Status:
Active, not recruiting
Trial end date:
2026-05-22
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Tirzepatide
Criteria
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