A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity (TRIUMPH-6)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06859268

27268

J1I-MC-GZQB (Other Identifier)

Details and patient eligibility

About

This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.

Enrollment: 586 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 Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes

• 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)
  • 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 3 patient groups, including a placebo group

Retatrutide Dose 1

Experimental group

Description:

Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks

Treatment:

Drug: Retatrutide

Retatrutide Dose 1 to Retatrutide Dose 2

Experimental group

Description:

Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks

Treatment:

Drug: Retatrutide

Retatrutide Dose 1 to Placebo

Placebo Comparator group

Description:

Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks

Treatment:

Drug: Placebo

Drug: Retatrutide