> 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-with-type-2-b440df9f-06ca-4617-9f30-0ebb26f70945 > Record changed: 2026-10-13 # A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight NCT05929079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Participants 1,152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Start date 2023-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) Number of sites 98 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Title and summary **Summary** The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Acronym** TRIUMPH-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Short title** A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Dates **Completion date** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **First posted** 2023-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Primary completion date** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Start date** 2023-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Size and sites **Actual participants** 1,152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Participants** 1,152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Number of sites** 98 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Identifiers **Registry ID** NCT05929079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **ClinicalTrials.gov ID** NCT05929079 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## 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/NCT05929079) ## Outcomes ### Primary outcomes 1. Percent Change from Baseline in Body Weight Timeframe: Baseline, Week 80 2. Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Timeframe: Baseline, Week 80 ### Secondary outcomes 1. Change from Baseline in Body Mass Index (BMI) Timeframe: Baseline, Week 80 2. Change from Baseline in Waist Circumference Timeframe: Baseline, Week 80 3. Change from Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 80 4. Change from Baseline in Diastolic Blood Pressure (DBP) Timeframe: Baseline, Week 80 5. Percent Change from Baseline in Total Cholesterol Timeframe: Baseline, Week 80 6. Percent Change from Baseline in Triglycerides Timeframe: Baseline, Week 80 7. Change from Baseline in Hemoglobin (A1c) HbA1c % Timeframe: Baseline, Week 80 8. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Timeframe: Baseline, Week 80 9. Change from Baseline in Fasting Glucose Timeframe: Baseline, Week 80 10. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) Timeframe: Baseline through Week 80 AUC is presented as a single average measure of AUC across the study duration. 11. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Timeframe: Baseline, Week 80 12. 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 Timeframe: Baseline to Week 80 A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the component. 13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset Timeframe: Baseline to Week 80 14. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset Timeframe: Week 80 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## Sites - Pinnacle Research Group, LLCAnniston, United States - Cullman Clinical TrialsCullman, United States - Preferred Research PartnersLittle Rock, United States - Core Healthcare GroupCerritos, United States - Velocity Clinical Research, WestlakeLos Angeles, United States - Valley Clinical Trials, Inc.Northridge, United States - Diablo Clinical Research, Inc.Walnut Creek, United States - Chase Medical Research, LLCWaterbury, United States - Excel Medical Clinical TrialsBoca Raton, United States - Teradan Clinical Trials, LLCBrandon, United States - Fleming Island Center for Clinical ResearchFleming Island, United States - Therafirst Medical CenterFort Lauderdale, United States - Clinical Site Partners LLC, dba Flourish ResearchMiami, United States - Quantum Clinical TrialsMiami Beach, United States - Renstar Medical ResearchOcala, United States - Clinical Research Center of FloridaPompano Beach, United States - Palm Beach Research CenterWest Palm Beach, United States - Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United States - NeuroTrials Research IncAtlanta, United States - Centricity Research Rincon PulmonologyRincon, United States - East-West Medical Research InstituteHonolulu, United States - Brengle Family MedicineIndianapolis, United States - MedVadis Research CorporationWaltham, United States - StudyMetrix ResearchCity of Saint Peters, United States - Las Vegas Medical ResearchLas Vegas, United States And 73 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/408215) ### Other registry identifiers (4) - 2023 - 2023-503658-11-00 - J1I-MC-GSA2 - J1I-MC-GZBK Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05929079) ## 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) - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### 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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