A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

• Status: Active, not recruiting
• Trial end date: 2023-06-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: LY3298176; Tirzepatide

Criteria

Inclusion Criteria:

• Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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