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Peptide
Retatrutide for Obesity (TRIUMPH-1 Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 80
Awards & highlights
TRIUMPH-1 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.Check my eligibility
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.See study design
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.
TRIUMPH-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with obstructive sleep apnea.
Select...
My knee X-ray shows moderate arthritis (Grade 2 or 3).
Select...
I have had knee pain for more than 12 weeks and it was painful on most days last month.
Select...
My BMI is over 30, or it's over 27 with a condition like high blood pressure, cholesterol issues, sleep apnea, or heart disease.
Select...
I haven't used PAP therapy for sleep issues in the last 4 weeks and don't plan to start.
TRIUMPH-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 80
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 80
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Percent Change From Baseline in Body Weight
Secondary outcome measures
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
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset
Change from Baseline in Body Mass Index (BMI)
+11 moreTRIUMPH-1 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Retatrutide Dose 3Experimental Treatment1 Intervention
Participants will receive retatrutide SC.
Group II: Retatrutide Dose 2Experimental Treatment1 Intervention
Participants will receive retatrutide SC.
Group III: Retatrutide Dose 1Experimental Treatment1 Intervention
Participants will receive retatrutide subcutaneously (SC).
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,214,829 Total Patients Enrolled
55 Trials studying Obesity
48,917 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with obstructive sleep apnea.I haven't used certain sleep or pain medications in the last 3 months.My knee X-ray shows moderate arthritis (Grade 2 or 3).I have had joint injections or procedures in the last 6 months.I have had pancreatitis.I have a joint condition that is not osteoarthritis.I haven't used stimulants like modafinil or amphetamines in the last 3 months.You have tried and failed to lose weight through dieting at least once before.I have received steroid injections in my joints within the last 3 months.I have had knee pain for more than 12 weeks and it was painful on most days last month.I have lost or gained more than 11 pounds in the last 3 months.I have diabetes.I have had or am planning to have surgery for weight loss.You use a dental appliance or another device to treat sleep apnea, other than PAP therapy.I have not taken any weight loss drugs in the last 90 days.You have a moderate-to-severe case of obstructive sleep apnea, as shown by a sleep test.I have been using PAP therapy for 3 months and can stop it for about a week for sleep studies.I or my family have a history of MTC or MEN-2.My BMI is over 30, or it's over 27 with a condition like high blood pressure, cholesterol issues, sleep apnea, or heart disease.I haven't used PAP therapy for sleep issues in the last 4 weeks and don't plan to start.You currently have symptoms and X-ray findings that match the American College of Rheumatology criteria for osteoarthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Retatrutide Dose 3
- Group 3: Retatrutide Dose 1
- Group 4: Retatrutide Dose 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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