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Retatrutide

LY3437943, LY-3437943

Quick Stats
Studies 83
Trials 32
Recruiting PHASE3 INTERVENTIONAL NCT07165028

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Tirzepatide
Type: DRUG
Description: Administered SC
Name: Retatrutide
Type: DRUG
Description: Administered SC
Name: Placebo
Type: DRUG
Description: Administered SC

Primary Outcomes

Measure: 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)
Description: 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

Trial Information

NCT ID

NCT07165028

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Eli Lilly and Company

Last Updated

December 15, 2025