> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/the-effect-of-retatrutide-once-weekly-on-cardiovascular-cfc35a4d-77fb-4075-9e42-1f2c64477b8e > Record changed: 2026-10-13 # The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes) NCT06383390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Participants 10,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Start date 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) Number of sites 743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Title and summary **Summary** The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Short title** The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Dates **Completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **First posted** 2024-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Primary completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Start date** 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Size and sites **Participants** 10,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Planned participants** 10,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Number of sites** 743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Identifiers **Registry ID** NCT06383390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **ClinicalTrials.gov ID** NCT06383390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## 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/NCT06383390) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Composite Endpoints Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF). 2. Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) ESKD is defined as the following individual components: persistent eGFR \\<15 mL/min/1.73 m\\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result. ### Secondary outcomes 1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) MACE-3 includes CV death, nonfatal MI, and nonfatal stroke. 2. Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF. 3. Time to Occurrence of All-Cause Death Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) Time to all-cause death. 4. Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) 5. Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline Timeframe: Randomization up to Study Completion (Approximate 248 Weeks) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 45 Years **Healthy volunteers** No ### Inclusion criteria - Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower - Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: - Coronary artery disease - Cerebrovascular disease - Peripheral arterial disease - Chronic kidney disease defined as: - eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg) - eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or - eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab) - A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2) ### Exclusion criteria Diabetes related: - Participants have Type 1 Diabetes or any history of diabetic ketoacidosis CV related: - Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization: - Myocardial infarction - Acute coronary syndrome - Stroke, or - Coronary, peripheral, or carotid artery arterial revascularization procedure. - Have acute decompensated heart failure requiring hospitalization. - Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: - Participants have an eGFR <20 mL/min/1.73 m^2 at screening - Have UACR >5000 mg/g (5.000 mg/mg) at screening - Have received any form of dialysis ≤ 90 days from the date of randomization - Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: - Participants have had or plan to have a surgical treatment for obesity, - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 - Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## Sites - Alabama Kidney ResearchAlabaster, United States - Central Research AssociatesBirmingham, United States - Alliance for Multispecialty Research, LLCDaphne, United States - Nephrology ConsultantsHuntsville, United States - Alliance for Multispecialty Research, LLCMobile, United States - Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United States - Sun City Clinical ResearchGlendale, United States - Arizona Kidney Disease & Hypertension Center (AKDHC) - ThunderbirdGlendale, United States - Helios Clinical Research - SAZ-PDV-026Paradise Valley, United States - Banner University Medical Center PhoenixPhoenix, United States - Phoenix Clinical LLCPhoenix, United States - Elite Clinical Studies, LLCPhoenix, United States - Absolute Clinical ResearchPhoenix, United States - Scottsdale Clinical TrialsScottsdale, United States - Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States - Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States - Cardiology and Medicine ClinicLittle Rock, United States - Trident Clinical Research Services, Inc.Apple Valley, United States - Invivo - BakersfieldBakersfield, United States - American Institute of ResearchBeverly Hills, United States - Hope Clinical Research, Inc.Canoga Park, United States - Valley Clinical Trials, Inc.Covina, United States - North Coast CardiologyEncinitas, United States - Neighborhood Healthcare Institute of HealthEscondido, United States - HB Clinical Trials - Fountain ValleyFountain Valley, United States And 718 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## References - PubMed 41160422 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41160422/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/479798) ### Other registry identifiers (3) - 2023 - 2023-508630-34-00 - J1I-MC-GZBO Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06383390) ## 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 (10) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition - [Cerebrovascular disorder](https://trialight.com/data/condition/cerebrovascular-disorder-a2841fac-69c8-56f7-967b-cae6af9a5fde.md) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) - [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) - [Peripheral arterial disease](https://trialight.com/data/condition/peripheral-arterial-disease-660376f2-3d22-5c83-86ea-1d146307e09b.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.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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