> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-retatrutide-ly3437943-in-participants-who-have-15265fcb-acc6-4c96-80a5-06c8a4f74049 > Record changed: 2026-10-13 # A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight NCT05929066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Participants 2,335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Start date 2023-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) Number of sites 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Acronym** TRIUMPH-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Short title** A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Dates **Completion date** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **First posted** 2023-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Primary completion date** 2026-04-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Start date** 2023-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Size and sites **Actual participants** 2,335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Participants** 2,335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Number of sites** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Identifiers **Registry ID** NCT05929066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **ClinicalTrials.gov ID** NCT05929066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/408235) ### Other registry identifiers (4) - 2023 - 2023-503657-35-00 - J1I-MC-GOA1 - J1I-MC-GZBJ Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929066) ## Related records ### Drugs (1) - [Retatrutide](https://trialight.com/data/asset/retatrutide-1c18d390-804a-469b-95a1-d654ddcca41e.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (3) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) - [Osteoarthritis, knee](https://trialight.com/data/condition/osteoarthritis-knee-217c801b-d59c-514b-92dd-3abbf23b24d7.md) ### Targets (3) - [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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