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

NCT05929066
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,335
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Lead sponsor
Eli Lilly and Company
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Start date
2023-07-10
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Number of sites
134
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Summary
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
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Acronym
TRIUMPH-1
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Short title
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-04-30
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First posted
2023-07-03
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Registry last updated
2026-08-21
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Primary completion date
2026-04-06
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Start date
2023-07-10
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Actual participants
2,335
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Participants
2,335
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
134
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05929066
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ClinicalTrials.gov ID
NCT05929066
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change From Baseline in Body Weight

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

  4. Percent Change from Baseline in Body Weight in Participants in Extension Subset

    Timeframe: Baseline, Week 104

  1. Percent Change from Baseline in Body Weight in Participants with Baseline BMI ≥ 35 kg/m2

    Timeframe: Baseline, Week 80

  2. Percentage of Participants who Achieve Body Weight Reduction of ≥ 5%

    Timeframe: Baseline through Week 80

  3. Percentage of Participants who Achieve Body Weight Reduction of ≥ 10%

    Timeframe: Baseline through Week 80

  4. Percentage of Participants who Achieve Body Weight Reduction of ≥ 15%

    Timeframe: Baseline through Week 80

  5. Percentage of Participants who Achieve Body Weight Reduction of ≥ 20%

    Timeframe: Baseline through Week 80

  6. Percentage of Participants who Achieve Body Weight Reduction of ≥ 25%

    Timeframe: Baseline through Week 80

  7. Percentage of Participants who Achieve Body Weight Reduction of ≥ 30%

    Timeframe: Baseline through Week 80

  8. Percentage of Participants who Achieve Body Weight Reduction of ≥ 35%

    Timeframe: Baseline through Week 80

  9. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 80

  10. Change from Baseline in Systolic Blood Pressure (SBP)

    Timeframe: Baseline, Week 80

  11. Percent Change from Baseline in Triglycerides

    Timeframe: Baseline, Week 80

  12. Percent Change from Baseline in Non-High-Density Lipoprotein (HDL)-Cholesterol

    Timeframe: Baseline, Week 80

  13. Percent Change form Baseline in Fasting Insulin

    Timeframe: Baseline, Week 80

  14. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

  16. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite-CT) Physical Function Composite Score

    Timeframe: Baseline, Week 80

  17. Change from Baseline in IWQOL-Lite-CT Psychosocial Composite Score

    Timeframe: Baseline, Week 80

  18. Change from Baseline in Body Mass Index (BMI)

    Timeframe: Baseline, Week 80

  19. Percentage of Participants who Achieve Waist-to-Height Ratio (WHtR) <0.5

    Timeframe: Baseline through Week 80

  20. Change from Baseline in HbA1c

    Timeframe: Baseline, Week 80

  21. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Timeframe: Baseline, Week 80

  22. Percentage of Participants with a Change in Medication Use

    Timeframe: Baseline through Week 80

  23. Percentage of Participants who Develop Type 2 Diabetes

    Timeframe: Baseline through Week 80

  24. Time to Onset of Type 2 Diabetes

    Timeframe: Baseline through Week 80

  25. Percent Change from Baseline in AHI for GSA1 Subset

    Timeframe: Baseline, Week 80

And 24 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Central Phoenix Medical ClinicPhoenix, United States
  • Arizona Research CenterPhoenix, United States
  • Medical InvestigationsLittle Rock, United States
  • Neuro-Pain Medical CenterFresno, United States
  • Valley ResearchFresno, United States
  • Artemis Institute for Clinical ResearchSan Diego, United States
  • University of Colorado Anschutz Medical CampusAurora, United States
  • Yale University School of MedicineNew Haven, United States
  • Chase Medical Research, LLCWaterbury, United States
  • Teradan Clinical Trials, LLCBrandon, United States
  • Suncoast Research GroupMiami, United States
  • New Horizon Research CenterMiami, United States
  • Clinical Neuroscience SolutionsOrlando, United States
  • Progressive Medical ResearchPort Orange, United States
  • NeuroTrials Research IncAtlanta, United States
  • North Georgia Clinical ResearchWoodstock, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Northwestern UniversityChicago, United States
  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research CooperativeSpringfield, United States
  • Brengle Family MedicineIndianapolis, United States
  • Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
  • MedVadis Research CorporationWaltham, United States
  • Great Lakes Research Group, Inc.Bay City, United States
  • StudyMetrix ResearchCity of Saint Peters, United States
  • Clinvest Research LLCSpringfield, United States

And 109 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-503657-35-00
  • J1I-MC-GOA1
  • J1I-MC-GZBJ
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (3)