A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
- Status
- RecruitingResults none
- Why it is watched
- population of special interest (non-obese / healthy / non-diabetic)
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
- Interventions
- Tirzepatide; Retatrutide; Placebo
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Phase and size
- Phase 3 · 4500 participants
- Dates
- Start 2025-10-15
Primary completion 2030-08 - Sponsor
- Eli Lilly and Company (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)Baseline up to Study Completion (about 224 weeks)
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.