Phase 3 · NCT05929066

TRIUMPH-1

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)

CompletedVerified

Registry record

Trial details

Trial
TRIUMPH-1
ClinicalTrials.gov ID
NCT05929066
Indication
Obesity, Overweight, Osteoarthritis, Knee, Obstructive Sleep Apnea
Phase
Phase 3
Study type
Interventional
Sponsor
Eli Lilly and Company
Enrolment
2,335
Status
Completed
Interventions
Drug: Retatrutide; Drug: Placebo
Comparator
Placebo
Eligible ages
18 Years – No maximum
Locations
134 sites · Australia, Brazil, Canada, Hungary, India, Mexico, Poland, Puerto Rico, Romania, Spain, United Kingdom, United States
Study start
10 Jul 2023
Primary completion
6 Apr 2026
Study completion
30 Apr 2026
View registry record →

Verification

Last verified
4 Sept 2026
Source
ClinicalTrials.gov
Registry last updated
21 Aug 2026

Endpoints

Primary

Percent Change From Baseline in Body Weight; 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 in Participants in Extension Subset

Secondary

Percent Change from Baseline in Body Weight in Participants with Baseline BMI ≥ 35 kg/m2; Percentage of Participants who Achieve Body Weight Reduction of ≥ 5%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 10%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 15%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 20%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 25%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 30%; Percentage of Participants who Achieve Body Weight Reduction of ≥ 35%; Change from Baseline in Waist Circumference; Change from Baseline in Systolic Blood Pressure (SBP); Percent Change from Baseline in Triglycerides; Percent Change from Baseline in Non-High-Density Lipoprotein (HDL)-Cholesterol; Percent Change form Baseline in Fasting Insulin; Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP); Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score; Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite-CT) Physical Function Composite Score; Change from Baseline in IWQOL-Lite-CT Psychosocial Composite Score; Change from Baseline in Body Mass Index (BMI); Percentage of Participants who Achieve Waist-to-Height Ratio (WHtR) <0.5; Change from Baseline in HbA1c; Change from Baseline in Estimated Glomerular Filtration Rate (eGFR); Percentage of Participants with a Change in Medication Use; Percentage of Participants who Develop Type 2 Diabetes; Time to Onset of Type 2 Diabetes; Percent Change from Baseline in AHI for GSA1 Subset; Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset; Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset; Percent Change from Baseline in Sleep Apnea-Specific Hypoxic Burden for GSA1 Subset; Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-related Impairment 8a T-score for GSA1 Subset; Change from Baseline in AHI Events Per Hour for GSA1 Subset in Participants with Baseline Body Mass Index (BMI) ≥ 35 kg/m2; Percentage of Participants who Achieve AHI < 5 for GSA1 Subset; Change from Baseline in ESS Score for GSA1 Subset; Change from Baseline in Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score; Change from Baseline in PROMIS Sleep Disturbance Short Form 8b T-Score for GSA1 Subset; Change from Baseline in Neck Circumference for GSA1 Subset; Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset; Percentage of Participants who Achieve ≥ 50% Reduction in the WOMAC Pain Subscale for GOA1 Subset; Percentage of Participants who Achieve ≥ 50% Reduction in the WOMAC Physical Function Subscale for GOA1 Subset; Change from Baseline in the WOMAC Pain Subscale Score for GOA1 Subset with Baseline BMI ≥ 35 kg/m2; Change from Baseline in the WOMAC Stiffness Subscale Score for GOA1 Subset; Change from Baseline in the WOMAC Total Score for GOA1 Subset; Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset; Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset; Percentage of Participants with an Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function for GOA1 Subset; Percentage of Participants with an Improved Categorical Shift in PGIS - Target Knee Pain for GOA1 Subset; Change from Baseline in EQ-5D-5L for GOA1 Subset; Percentage of Participants with a Change in Use of Allowed Concomitant Pain Medication for GOA1 Subset; Change from Baseline in Joint Space Width for GOA1 Subset; Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

Registry monitoring

Latest Trial Changes

FieldChangeDetectedSource
Recruitment statusActive, not recruitingCompleted4 Sept 2026ClinicalTrials.gov
Enrolment214023354 Sept 2026ClinicalTrials.gov
Primary completion date2026-12-312026-04-064 Sept 2026ClinicalTrials.gov
Study completion dateData pending2026-04-304 Sept 2026ClinicalTrials.gov
Primary endpointsData pendingPercent Change From Baseline in Body Weight; 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 in Participants in Extension Subset4 Sept 2026ClinicalTrials.gov