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Peptide

Retatrutide for Obesity (TRIUMPH-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously diagnosed with OSA

Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening

Must not have

Have had pancreatitis

Have joint disease other than osteoarthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 80

Awards & highlights

Pivotal Trial

Summary

This trial evaluates the safety & effectiveness of a new treatment for obesity/overweight, knee OA, & obstructive sleep apnea over 89 weeks with 24 visits.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, common concerns when testing new treatments for obesity might include gastrointestinal issues (like nausea or diarrhea), potential thyroid problems given the exclusion criteria related to MTC/MEN-2 syndrome, injection site reactions if applicable, and possibly effects on blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with obstructive sleep apnea.

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

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I have had knee pain for more than 12 weeks and it was painful on most days last month.

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My BMI is over 30, or it's over 27 with a condition like high blood pressure, cholesterol issues, sleep apnea, or heart disease.

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I haven't used PAP therapy for sleep issues in the last 4 weeks and don't plan to start.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pancreatitis.

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I have a joint condition that is not osteoarthritis.

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I have diabetes.

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I have had or am planning to have surgery for weight loss.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 80

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 80

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 80 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)