Retatrutide for Obesity

(TRIUMPH-6 Trial)

Recruiting at 52 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for individuals with obesity who have successfully lost weight. Participants will first undergo an 80-week phase where everyone takes Retatrutide dose 1, followed by a 36-week phase where they'll be randomly assigned to continue with either the same or a different dose of Retatrutide, or switch to a placebo.

Inclusion Criteria

Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria

I or my family have a history of MTC or MEN-2.

I have not had a heart attack, stroke, or been hospitalized for heart issues in the last 3 months.

Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening

Treatment Details

Interventions

• Retatrutide (Other)

Trial Overview The study tests how well Retatrutide helps maintain weight loss in obese individuals over approximately two and a half years. It involves an initial period where all participants receive the drug, then a randomized phase comparing two doses of Retatrutide against a placebo.

Participant Groups

Group I: Retatrutide Dose 1 to Retatrutide Dose 2 Experimental Treatment 1 Intervention

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

Group II: Retatrutide Dose 1 Experimental Treatment 1 Intervention

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

Group III: Retatrutide Dose 1 to Placebo Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University