DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05929066

TRIUMPH-1

Active not recruitingPhase 3

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

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)

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

134

Recruiting sites

—

Enrollment

2,335

actual

Study population

Obesity / overweight, Osteoarthritis, Sleep apnea

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•WOMAC pain•AHI, 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 IDNCT05929066
Org study ID18557
Secondary ID2023-503657-35-00EU Trial Number
Secondary IDJ1I-MC-GOA1ISA Eli Lilly and Company
Secondary IDJ1I-MC-GSA1ISA Eli Lilly and Company
Secondary IDJ1I-MC-GZBJMaster Protocol Eli Lilly and Company

Timeline

Milestones

Study first posted2023-07-03actual
Study start2023-07-10actual
Primary completion2026-04-06actual
Last update posted2026-05-22actual
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritisSleep apnea

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
–hypertension
–dyslipidemia
–obstructive sleep apnea, or
–cardiovascular disease
•History of of at least one unsuccessful dietary effort to reduce body weight

GOA1 Inclusion Criteria:

•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.

GSA1 Inclusion Criteria:

•Previously diagnosed with OSA
•Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
•For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
•If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

GZBJ Addenda (2) inclusion criteria:

•Have completed the final treatment visit of GZBJ Week 80.

Exclusion criteria

•Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
•Have taken 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.
•Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
•Have had pancreatitis.

GOA1 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.

GSA1 exclusion criteria

•Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
•Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
•Use a dental appliance or other device to treat OSA other than PAP therapy.

GZBJ Addenda (2) exclusion criteria

•Have had study intervention discontinuation.
•Have had permanent dose reduction.

Endpoints (18)

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

Other clinical outcomes
8
Weight & body composition
4
Glycemic / diabetes
2
Patient-reported / QoL
2
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 80

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percent Change from Baseline in Body Weight to

Time frame:Baseline, Week 104

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 80

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 80

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Percent Change form Baseline in Fasting Insulin

Time frame:Baseline, Week 80

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 80

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline, Week 80

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to Week 80

composite event, improvement

componentsFOSQ-10 total score change from baseline, FOSQ vigilance domain score change from baseline, FOSQ activity level domain score change from baseline

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline through Week 80

AUC₀–∞

concentration, descriptive

Other clinical outcomes

8 endpoints
Primary/protocol endpoint

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset

Time frame:Baseline, Week 80

WOMAC pain

change from baseline, improvement

Primary/protocol endpoint

Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset

Time frame:Baseline, Week 80

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset

Time frame:Baseline, Week 80

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset

Time frame:Baseline, Week 80

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in AHI for GSA1 Subset

Time frame:Baseline, Week 80

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset

Time frame:Baseline to Week 80

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset

Time frame:Week 80

OSA responder

threshold achievement, improvement

componentsAHI, change, PGI, change

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.