TRIUMPH-2

Active not recruitingPhase 3

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

—

Enrollment

1,000

estimated

Study population

Obesity / overweight, Sleep apnea, Type 2 diabetes

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•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 IDNCT05929079

Org study ID18558

Secondary ID2023-503658-11-00EU Trial Number

Secondary IDJ1I-MC-GSA2ISA Eli Lilly and Company

Secondary IDJ1I-MC-GZBKMaster Protocol Eli Lilly and Company

Timeline

Milestones

Study first posted2023-07-03actual

Study start2023-07-11actual

Last update posted2026-04-13actual

Primary completion2026-05estimated (month precision)

Study completion2026-05estimated (month precision)

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Obesity / overweightSleep apneaType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)

•Have Type 2 Diabetes (T2D)

•Are on stable treatment for T2D for at least 90 days

•Have a history of at least one unsuccessful dietary effort to lose body weight.

GSA2 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.

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 Type 1 diabetes

•Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

•Have had pancreatitis

GSA2 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.

Endpoints (16)

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

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 80

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

Change from Baseline in Hemoglobin (A1c) HbA1c %

Time frame:Baseline, Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 80

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints

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

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 80

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 80

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 80

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

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/low confidence

A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset

Time frame:Baseline to Week 80

composite event, improvement

componentsPGI, change

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

4 endpoints

Primary/protocol endpoint

Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

Time frame:Baseline, Week 80

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 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 GSA2 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 GSA2 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

Retatrutide for the treatment of obesity, obstructive sleep apnea and knee osteoarthritis: Rationale and design of the TRIUMPH registrational clinical trials.
Diabetes, obesity & metabolism2026 Jan (month)PMID41090431doi:10.1111/dom.70209via pubmed acronym asset candidate

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.