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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Metabolic Dysfunction-Associated Steatotic Liver Disease
Date of first enrollment	27/11/2025
Target sample size	4500
Countries of recruitment	United States,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Mexico,Japan,Romania,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Ukraine,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	DRUG: Tirzepatide(Other Name: LY3298176) Administered SC DRUG: Retatrutide(Other Name: LY3437943) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Tirzepatide (TZ01) Participants will receive tirzepatide subcutaneously (SC) Interventions: Drug: Tirzepatide Placebo Comparator: Placebo (TZ01) Participants will receive placebo SC Interventions: Drug: Placebo Experimental: Retatrutide (RT01) Participants will receive retatrutide SC Interventions: Drug: Retatrutide Placebo Comparator: Placebo (RT01) Participants will receive placebo SC Interventions: Drug: Placebo

Outcome(s)

Primary Outcome

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) [ Time Frame: 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 Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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