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Retatrutide-Obesity

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What retatrutide clinical trials are being conducted in people with obesity or overweight?

The TRIUMPH clinical trial program evaluates the safety and efficacy of investigational doses of retatrutide for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity.

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Content Overview

What Is the Purpose of the TRIUMPH Clinical Trial Program for Chronic Weight Management?

What Are the TRIUMPH Phase 3 Clinical Trials Evaluating Retatrutide in Obesity or Overweight?

What Are the Key Inclusion Criteria and Primary Endpoints for the TRIUMPH‑1 Knee Osteoarthritis and OSA Substudies?
What Are the Key Inclusion Criteria and Primary Endpoints for the TRIUMPH‑2 OSA Substudy?

References

What Is the Purpose of the TRIUMPH Clinical Trial Program for Chronic Weight Management?

The TRIUMPH clinical trial program assesses the efficacy and safety of investigational doses of retatrutide for weight management in people with obesity, or overweight with at least one weight-related comorbidity (Overview of the TRIUMPH Phase 3 Clinical Trial Program of Retatrutide for Obesity).1

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What Are the TRIUMPH Phase 3 Clinical Trials Evaluating Retatrutide in Obesity or Overweight?

Overview of the TRIUMPH Phase 3 Clinical Trial Program of Retatrutide for Obesity
Trial and Target Population	Key Inclusion Criteria	Retatrutide Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Global trials
TRIUMPH-11,2 in People With Obesity or Overweight NCT05929066	BMI ≥30 kg/m², or BMI ≥27 kg/m² with ≥1 BW-related comorbidity without T2Da	Administered SC	PBO	Percent CFB in BW	80 weeks
TRIUMPH-21,3 in People With T2D and Obesity or Overweight NCT05929079	BMI ≥27 kg/m² T2D	Administered SC	PBO	Percent CFB in BW	80 weeks
TRIUMPH-31,4 in People With Obesity and CV Disease NCT05882045	BMI ≥35 kg/m² Established CV disease with ≥1 of the following: prior MI prior ischemic or hemorrhagic stroke, or symptomatic PAD	Administered SC	PBO	Percent CFB in BW	80 weeks
TRIUMPH-41,5 in People With Obesity or Overweight and Knee OA NCT05931367	BMI ≥27 kg/m² Index knee pain for >12 weeks prior to screening and for >15 days over previous month Knee X-ray with moderate radiographic changesb Meets ACR criteria (clinical and radiological) for OA	Administered SC	PBO	CFB in WOMAC Pain Subscale Score Percent CFB in BW	68 weeks
TRIUMPH-56 Compared With Tirzepatide in Adults Who Have Obesity NCT06662383	Obesity and a history of at least one self-reported unsuccessful dietary effort to reduce BW	Administered SC	Tirzepatide	Percent CFB in BW	80 weeks
TRIUMP-67 in Individuals With Obesity for Maintenance of Weight Reduction NCT06859268	Obesity and a history of at least one self-reported unsuccessful dietary effort to reduce BW	Administered SC	PBO	Percent CFB in BW	116 weeks
TRIUMPH-78 in Participants Who Have Obesity or Overweight and Chronic Low Back Pain NCT07035093	History of axial-predominant low back pain Pain that is restricted to the low back or with a referral pattern limited to the proximal legs BMI ≥27.0 kg/m² at screening History of at least one self-reported unsuccessful dietary effort to lose BW	Administered SC	PBO	Change from baseline in pain intensity per numeric rating scale Percent change from baseline in BW	72 weeks
TRIUMPH-89 in Participants With Obesity or Overweight Without T2D NCT07232719	BMI ≥30 kg/m², or BMI ≥27 kg/m² with ≥1 BW-related comorbidity without T2Dc History of at least one unsuccessful attempt to lose weight by dieting	Administered SC	PBO	Percent change from baseline in BW	56 weeks
TRIUMPH-910 in Participants Without Type 2 Diabetes Who Have Obesity or Overweight Using Different Dose Escalation Schemes (TRIUMPH-9) NCT07357415	BMI ≥ 30 kg/m², or BMI ≥ 27 kg/m² with ≥1 BW-related comorbidity without T2Dc History of at least one unsuccessful attempt to lose weight by dieting	Administered SC	N/A	Percent change from baseline in BW	104 weeks
TRIUMPH-Outcomes11 in People With Obesity and ASCVD and/or CKD NCT06383390	BMI ≥27.0 kg/m² With or without T2Dd Established ASCVDe and/or CKDf	Administered SC	PBO	Time to first occurrence of composite endpointsg Time to first occurrence of composite endpoint of ESKDh, ≥40% sustained decline in eGFRi, CV death, or renal death	248 weeks

Abbreviations: ACR = American College of Rheumatology; ASCVD = atherosclerotic cardiovascular disease; BMI = body mass index; BW = body weight; CFB = change from baseline; CKD = chronic kidney disease; CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; CV = cardiovascular; eGFR = estimated glomerular filtration rate; ESKD = end-stage kidney disease; HbA1c = glycated hemoglobin; HF = heart failure; MI = myocardial infarction; N/A = not applicable; OA = osteoarthritis; PAD = peripheral arterial disease; PBO = placebo; SC = subcutaneously; T2D = type 2 diabetes; UACR = urine albumin-to-creatinine ratio; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.

aComorbidities included hypertension, abnormal levels of lipid, obstructive sleep apnea, or CV disease.

bKellgren-Lawrence grade 2 of 3 confirmed by central reading at screening.

cComorbidities included high blood pressure, abnormal levels of lipid, obstructive sleep apnea, or heart disease.

dIf patient has T2D, their HbA1c must be ≤10%.

eASCVD as evidenced by one of the following: coronary artery disease, cerebrovascular disease, or PAD.

fCKD was defined as eGFR <45 mL/min/1.73 m² and UACR >30 mg/g, eGFR <60 mL/min/1.73 m² and UACR >100 mg/g, or eGFR <75 mL/min/1.73 m² and UACR >300 mg/g (eGFR is calculated by central lab based on CKD-EPI creatinine-cystatin C equation).

gA composite endpoint includes nonfatal MI, nonfatal stroke, CV death, or hospitalization or urgent visit due to HF.

hESKD is defined as the following individual components: persistent eGFR <15 mL/min/1.73 m² confirmed by 2 measurements at least 4 weeks apart, initiation of dialysis for at least 30 days, or receiving a kidney transplant.

iSustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.

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What Are the Key Inclusion Criteria and Primary Endpoints for the TRIUMPH‑1 Knee Osteoarthritis and OSA Substudies?

The main TRIUMPH-1 clinical protocol evaluates safety and efficacy of retatrutide in adults with obesity or overweight. In addition, 2 subsets of participants will be evaluated who also have

knee osteoarthritis, or
obstructive sleep apnea (OSA).1,2

The primary endpoints and key inclusion criteria for these substudies are presented in TRIUMPH-1 Knee Osteoarthritis and Obstructive Sleep Apnea Substudies.

TRIUMPH-1 Knee Osteoarthritis and Obstructive Sleep Apnea Substudies1,3
Substudy	Key Inclusion Criteria	Retatrutide Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Global trials
TRIUMPH-1 Knee OA Substudy NCT05929066 (GOA1)	Index knee pain for >12 weeks prior to screening and for >15 days over previous month Knee X-ray with moderate radiographic changesa Meets ACR criteria (clinical and radiological) for OA	Administered SC	PBO	CFB in WOMAC Pain Subscale Score	80 weeks
TRIUMPH-1 OSA Substudy NCT05929066 (GSA1)	OSA diagnosis AHI ≥15 on polysomnography at screening	Administered SC	PBO	CFB in AHI events/h	80 weeks

Abbreviations: ACR = American College of Rheumatology; AHI = apnea-hypopnea index; CFB = change from baseline; OA = osteoarthritis; OSA = obstructive sleep apnea; PBO = placebo; SC = subcutaneously; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.

aKellgren-Lawrence grade 2 or 3 confirmed by central reading at screening.

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What Are the Key Inclusion Criteria and Primary Endpoints for the TRIUMPH‑2 OSA Substudy?

The main TRIUMPH-2 clinical protocol evaluates safety and efficacy of retatrutide in adults with obesity or overweight and who also have type 2 diabetes. In addition, a subset of participants with OSA will also be evaluated.1,3

The primary endpoint and key inclusion criteria for this substudy are presented in TRIUMPH-2 Obstructive Sleep Apnea Substudy.

TRIUMPH-2 Obstructive Sleep Apnea Substudy1,3
Substudy	Key Inclusion Criteria	Retatrutide Groups	Comparator	Primary Endpoint	Primary Timepoint
Global trial
TRIUMPH-2 OSA Substudy NCT05929079 (GSA2)	OSA diagnosis AHI ≥15 on polysomnography at screening	Administered SC	PBO	CFB in AHI	80 weeks

Abbreviations: AHI = apnea-hypopnea index; CFB = change from baseline; OSA = obstructive sleep apnea; PBO = placebo; SC = subcutaneously.

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References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Giblin K, Kaplan LM, Somers VK, et al. Retatrutide for the treatment of obesity, obstructive sleep apnea, and knee osteoarthritis: Rationale and design of the TRIUMPH registrational clinical trials. Diabetes Obes Metab. Published online October 15, 2025. https://doi.org/10.1111/dom.70209

2A study of retatrutide (LY3437943) in participants who have obesity or overweight (TRIUMPH-1). ClinicalTrials.gov identifier: NCT05929066. Updated September 26, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05929066

3A study of retatrutide (LY3437943) in participants with type 2 diabetes mellitus who have obesity or overweight (TRIUMPH-2). Clinicaltrials.gov identifier: NCT05929079. Updated November 5, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05929079

4A study of retatrutide (LY3437943) in participants with obesity and cardiovascular disease (TRIUMPH-3). Clinicaltrials.gov identifier: NCT05882045. Updated October 10, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05882045

5A study of retatrutide (LY3437943) once weekly in participants who have obesity or overweight and osteoarthritis of the knee (TRIUMPH-4). Clinicaltrials.gov identifier: NCT05931367. Updated April 22, 2025. Accessed December 5, 2025. https://clinicaltrials.gov/study/NCT05931367

6A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5). Clinicaltrials.gov identifier: NCT06662383. Updated April 27, 2025. Accessed February 11, 2025. https://clinicaltrials.gov/study/NCT06662383

7A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity (TRIUMPH-6). Clinicaltrials.gov identifier: NCT06859268. Updated October 16, 2025. Accessed February 11, 2025. https://clinicaltrials.gov/study/NCT06859268

8A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7). Clinicaltrials.gov identifier: NCT07035093. Updated February 10, 2026. Accessed February 11, 2026. https://clinicaltrials.gov/study/NCT07035093

9A study of retatrutide (LY3437943) in participants with obesity or overweight (TRIUMPH-8). ClinicalTrials.gov identifier: NCT07232719. Updated January 6, 2026. Accessed February 17, 2026. https://clinicaltrials.gov/study/NCT07232719

10A study of retatrutide (LY3437943) in participants without type 2 diabetes who have obesity or overweight (TRIUMPH-9). ClinicalTrials.gov identifier: NCT07357415. Updated February 10, 2026. Accessed February 17, 2026. https://clinicaltrials.gov/study/NCT07357415

11The effect of retatrutide once weekly on cardiovascular outcomes and kidney outcomes in adults living with obesity (TRIUMPH-Outcomes). Clinicaltrials.gov identifier: NCT06383390. Updated January 21, 2026. Accessed February 5, 2026. https://clinicaltrials.gov/study/NCT06383390

Date of Last Review: February 11, 2026

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