A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Retatrutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662383

2024-511450-49-00 (EU Trial (CTIS) Number)

18585

J1I-MC-GZBP (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.

• 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)
  • coronary revascularization
  • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 2 patient groups

Retatrutide

Experimental group

Description:

Participants will receive retatrutide administered subcutaneously (SC)

Treatment:

Drug: Retatrutide

Tirzepatide

Active Comparator group

Description:

Participants will receive tirzepatide administered SC

Treatment:

Drug: Tirzepatide