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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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TRIUMPH Clinical Trial Program: Retatrutide for the Treatment of Obesity

The TRIUMPH clinical trial program assesses the efficacy and safety of investigational doses of retatrutide for chronic 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).

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 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-22 in People With T2D and Obesity or Overweight NCT05929079	BMI ≥27 kg/m² T2D	Administered SC	PBO	Percent CFB in BW	80 weeks
TRIUMPH-33 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-44 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-Outcomes5 in People With Obesity and ASCVD and/or CKD NCT06383390	BMI ≥27.0 kg/m² With or without T2Dc Established ASCVDd and/or CKDe	Administered SC	PBO	Time to first occurrence of composite endpointsf Time to first occurrence of composite endpoint of ESKDg, ≥40% sustained decline in eGFRh, 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; EKSD = end-stage kidney disease; HbA1c = glycated hemoglobin; HF = heart failure; MI = myocardial infarction; 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, dyslipidemia, obstructive sleep apnea, or CV disease.

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

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

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

eCKD 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).

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

gESKD 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.

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

TRIUMPH-1 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

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

TRIUMPH-1 Knee Osteoarthritis and Obstructive Sleep Apnea Substudies1
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.

TRIUMPH-2 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.2

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

TRIUMPH-2 Obstructive Sleep Apnea Substudy2
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.

References

1A 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

2A 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

3A 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

4A 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 July 19, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05931367

5The effect of retatrutide once weekly on cardiovascular outcomes and kidney outcomes in adults living with obesity (TRIUMPH-Outcomes). Clinicaltrials.gov identifier: NCT06383390. Updated November 19, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT06383390

Date of Last Review: November 27, 2024

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