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

NCT07165028 · Recruiting

Last updated 2026-05-28

This clinical trial is testing different investigational treatments in adults with fatty liver disease to see how they affect the time until serious liver-related health problems occur.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 4,500 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-10 · est. completion 2032-08

Where 562 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT07165028 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC
Retatrutide also known as LY3437943 Drug

Administered SC
Placebo Drug

Administered SC

Main thing measured	Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
Sponsor	Eli Lilly and Company
Conditions studied	Metabolic Dysfunction-Associated Steatotic Liver Disease
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07165028 ↗