Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT07165028·Phase 3·INTERVENTIONAL

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

RetatrutideTirzepatideGlucagonOtherRecruiting

Status

Recruiting

Phase

Phase 3

Enrollment

4,500

Locations

563

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Tirzepatide

Administered SC

DRUG

Retatrutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Sep 10, 2025

  2. Study start

    Oct 15, 2025

  3. Primary completion

    Aug 2030

  4. Study completion

    Aug 2032

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

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 outcomes

Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

Time frame · Baseline, Week 104

Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)

Time frame · Baseline, Week 104

Percent Change from Baseline in Liver Fat Content (LFC)

Time frame · Baseline, Week 104

Time to Occurrence of Progression to Cirrhosis

Time frame · Baseline up to Study Completion (about 224 weeks)

Change from Baseline in Aspartate Aminotransferase (AST)

Time frame · Baseline, Study Completion (about 224 weeks)

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame · Baseline, Study Completion (about 224 weeks)

Change from Baseline in Body Weight

Time frame · Baseline, Study Completion (about 224 weeks)

Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK)

Time frame · Baseline, Week 104

Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)

Time frame · Baseline up to Study Completion (about 224 weeks)

MACE-3 composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

563 registered 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. Showing up to 24 locations stored in the fast local snapshot.

MFA Clinical Research

Tuscaloosa, Alabama, United States

The Institute for Liver Health II dba Arizona Clinical Trials - Chandler

Chandler, Arizona, United States

Spectrum Research Institute

Gilbert, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health - Peoria

Peoria, Arizona, United States

Epic Medical Research-Sun City

Sun City, Arizona, United States

The Institute for Liver Health II dba Arizona Clinical Trials - Tucson

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Arkansas Gastroenterology - North Little Rock

North Little Rock, Arkansas, United States

San Fernando Valley Health Institute

Canoga Park, California, United States

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States

Fresno Clinical Research Center

Fresno, California, United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California, United States

Orange County Research Center

Lake Forest, California, United States

Om Research LLC

Lancaster, California, United States

Ark Clinical Research

Long Beach, California, United States

Los Angeles Institute for Metabolic Research

Los Angeles, California, United States

United Medical Doctors - Murrieta

Murrieta, California, United States

Knowledge Research Center

Orange, California, United States

California Liver Research Center

Pasadena, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Medical Associates Research Group

San Diego, California, United States

Quest Clinical Research

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

South Denver Gastroenterology

Englewood, Colorado, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsRetatrutide trial dashboard →DatabaseRetatrutide database entry →ResearchRetatrutide research guide →MarketRetatrutide comparison →TrialsTirzepatide trial dashboard →DatabaseTirzepatide database entry →ResearchTirzepatide research guide →TrialsGlucagon trial dashboard →DatabaseGlucagon database entry →ResearchGlucagon research guide →Research vendor recordAscension Peptides →Research vendor recordNura Peptide →Research vendor recordEZ Peptides →Research vendor recordNOVA Labs →