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TRIUMPH-4

CompletedPhase 3

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

49

Recruiting sites

Enrollment

445

actual

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

BMI ≥27

Primary endpoints

WOMAC painBody weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05931367
Org study ID18583
Secondary ID2023-503660-17-00EU Trial Number
Secondary IDJ1I-MC-GZBNEli Lilly and Company

Timeline

Milestones

Study first posted2023-07-05actual
Study start2023-08-01actual
Primary completion2025-11-14actual
Study completion2025-11-14actual
Last update posted2026-01-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month.
Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

Exclusion criteria

Have had steroid joint injections within 90 days of screening.
Have had other joint injections and procedures within 6 months of screening.
Have joint disease other than osteoarthritis.
Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.
Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a prior or planned surgical treatment for obesity.
Have diabetes mellitus.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
4
Other clinical outcomes
4
Weight & body composition
3
Glycemic / diabetes
1
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 68

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 68

percent change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 68

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 68

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 68

SF-36 physical

change from baseline, improvement

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Time frame:Baseline, Week 68

WOMAC pain

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the WOMAC Physical Function Subscale Score

Time frame:Baseline, Week 68

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score

Time frame:Baseline, Week 68

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score

Time frame:Baseline, Week 68

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.