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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~week 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 80 for reporting.

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 more

TRIUMPH-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.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,214,499 Total Patients Enrolled
55 Trials studying Obesity
49,119 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company

Media Library

Retatrutide (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT05929066 — Phase 3
Obesity Research Study Groups: Placebo, Retatrutide Dose 3, Retatrutide Dose 1, Retatrutide Dose 2
Obesity Clinical Trial 2023: Retatrutide Highlights & Side Effects. Trial Name: NCT05929066 — Phase 3
Retatrutide (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929066 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with utilizing Retatrutide Dose 1?

"There is extant clinical proof affirming that Retatrutide Dose 1 is safe, thus it was given a score of 3 by the Power team. This rating was determined due to being in Phase 3 and having multiple rounds of data supporting efficacy and safety."

Answered by AI

What is the current tally of medical centers taking part in this experiment?

"This study can be accessed at multiple medical centres, including the Arizona Research Center in Little Rock, Medical Investigations in Fresno, and Valley Research in San Diego. In total there are 169 sites available for participation."

Answered by AI

Are there any vacancies available in this research investigation?

"Per clinicaltrials.gov, recruitment for this trial has ceased as of June 26th 2023. This research project was first posted on August 7th 2023 and is no longer actively recruiting patients; however, there are over 1800 other studies presently seeking participants."

Answered by AI

Who else is applying?

What site did they apply to?
Central Phoenix Medical Clinic
Palm Research Center Tenaya
Juno Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

Need to loos4 weight. I’ve have tried 4 times. I need help before I die. I’ve tried different weight loss plans with no results.
PatientReceived no prior treatments
I have dieted all my adult life, and nothing works long term.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What are the drugs? What is the next step? How does this medication work?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
2023. "A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05929066.
All > Montreal > Honolulu
~1400 spots leftby Apr 2026
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