> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-master-protocol-of-multiple-agents-in-adults-with-e6b397f9-90a9-42e3-81a6-c73e9176a43c > Record changed: 2026-10-13 # A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) NCT07165028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Participants 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Start date 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) Number of sites 565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Title and summary **Summary** The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Short title** A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Official title** A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Dates **Completion date** 2032-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **First posted** 2025-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Primary completion date** 2030-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Start date** 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Size and sites **Participants** 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Planned participants** 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Number of sites** 565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Identifiers **Registry ID** NCT07165028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **ClinicalTrials.gov ID** NCT07165028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) Timeframe: Baseline up to Study Completion (about 224 weeks) Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality ### Secondary outcomes 1. Change from Baseline in Enhanced Liver Fibrosis (ELF) Score Timeframe: Baseline, Week 104 2. Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM) Timeframe: Baseline, Week 104 3. Percent Change from Baseline in Liver Fat Content (LFC) Timeframe: Baseline, Week 104 4. Time to Occurrence of Progression to Cirrhosis Timeframe: Baseline up to Study Completion (about 224 weeks) 5. Change from Baseline in Aspartate Aminotransferase (AST) Timeframe: Baseline, Study Completion (about 224 weeks) 6. Change from Baseline in Alanine Aminotransferase (ALT) Timeframe: Baseline, Study Completion (about 224 weeks) 7. Change from Baseline in Body Weight Timeframe: Baseline, Study Completion (about 224 weeks) 8. Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK) Timeframe: Baseline, Week 104 9. Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3) Timeframe: Baseline up to Study Completion (about 224 weeks) MACE-3 composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have liver fat content ≥8% - Have ELF score of ≥9 and ≤10.8 at screening - Have VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening ### Exclusion criteria - Have any other type of liver disease other than MASLD - Have a body mass index (BMI) <25 kilogram per square meter (kg/m2) - Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy) - Have lost more than 11 pounds within the 3 months prior to screening - Have a hemoglobin A1c (HbA1c) greater than 10% - Have type 1 diabetes Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Sites - MFA Clinical ResearchTuscaloosa, United StatesRecruiting - The Institute for Liver Health II dba Arizona Clinical Trials - ChandlerChandler, United StatesRecruiting - Spectrum Research InstituteGilbert, United StatesRecruiting - The Institute for Liver Health II dba Arizona Liver Health - PeoriaPeoria, United StatesRecruiting - Epic Medical Research-Sun CitySun City, United StatesRecruiting - The Institute for Liver Health II dba Arizona Clinical Trials - TucsonTucson, United StatesRecruiting - Del Sol Research Management, LLCTucson, United StatesRecruiting - Arkansas Gastroenterology - North Little RockNorth Little Rock, United StatesRecruiting - San Fernando Valley Health InstituteCanoga Park, United StatesRecruiting - Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting - Fresno Clinical Research CenterFresno, United StatesRecruiting - UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United StatesRecruiting - Orange County Research CenterLake Forest, United StatesRecruiting - Om Research LLCLancaster, United StatesRecruiting - Ark Clinical ResearchLong Beach, United StatesRecruiting - Los Angeles Institute for Metabolic ResearchLos Angeles, United StatesRecruiting - United Medical Doctors - MurrietaMurrieta, United StatesRecruiting - Knowledge Research CenterOrange, United StatesRecruiting - California Liver Research CenterPasadena, United StatesRecruiting - Artemis Institute for Clinical ResearchRiverside, United StatesRecruiting - Medical Associates Research GroupSan Diego, United StatesRecruiting - Quest Clinical ResearchSan Francisco, United StatesRecruiting - University of Colorado Anschutz Medical CampusAurora, United StatesRecruiting - South Denver GastroenterologyEnglewood, United StatesRecruiting - Medical Research Center of ConnecticutHamden, United StatesRecruiting And 540 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/651596) ### Other registry identifiers (3) - 2025 - 2025-522674-36-00 - N1T-MC-MALO Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07165028) ## Related records ### Drugs (2) - [Retatrutide](https://trialight.com/data/asset/retatrutide-1c18d390-804a-469b-95a1-d654ddcca41e.md) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.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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