Retatrutide for Obesity
(TRIUMPH-1 Trial)

Recruiting in Palo Alto (17 mi)

+200 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 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 adults with obesity or overweight, having a BMI ≥30 kg/m², or ≥27 kg/m² with conditions like hypertension. Participants should have tried and failed to lose weight through dieting, may have knee pain due to osteoarthritis for over 12 weeks, and/or moderate-to-severe obstructive sleep apnea but not on PAP therapy. Exclusions include diabetes patients, those with certain genetic syndromes (MTC or MEN-2), history of pancreatitis, recent significant weight changes (>5kg in 90 days), joint diseases other than OA, prior obesity surgery plans.

Inclusion Criteria

I have been diagnosed with obstructive sleep apnea.

My knee X-ray shows moderate arthritis (Grade 2 or 3).

You have tried and failed to lose weight through dieting at least once before.

See 6 more

Exclusion Criteria

I haven't used certain sleep or pain medications in the last 3 months.

I have had joint injections or procedures in the last 6 months.

I have had pancreatitis.

See 9 more

Treatment Details

Interventions

Retatrutide (Peptide)

Trial OverviewThe study tests Retatrutide's effectiveness and safety in reducing body weight over approximately 89 weeks compared to a placebo. It includes participants who also suffer from knee osteoarthritis or obstructive sleep apnea. The trial involves up to 24 visits where the intervention's impact on these conditions will be monitored.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Retatrutide Extension PeriodExperimental Treatment1 Intervention

Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.

Group II: Retatrutide Dose 3Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group III: Retatrutide Dose 2Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group IV: Retatrutide Dose 1Experimental Treatment1 Intervention

Participants will receive retatrutide subcutaneously (SC).