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

{ "SYNERGY-Outcomes Study for Metabolic Dysfunction-Associated Steatotic Liver Disease", "This study, called SYNERGY-Outcomes, is looking into whether two medications, tirzepatide and retatrutide, can prevent serious liver problems (Major Adverse Liver Outcomes or MALO) in adults with a high risk of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). MASLD is a condition where too much fat builds up in the liver. You might be able to join if you are an adult with MASLD and specific non-invasive test results showing certain levels of liver fat and stiffness. Participants will be randomly assigned to receive either tirzepatide, retatrutide, or a placebo (an inactive substance) through injections under the skin. The study aims to enroll about 4,500 adults and will last for approximately 224 weeks, with the main goal being to see if these medications can prevent MALO.", "design": "This is an interventional study that plans to enroll about 4,500 adult participants. Participants will be randomly assigned to receive one of two active drugs or a placebo.", "commitments": "You may have up to approximately 25 to 30 clinic visits over about 224 weeks to monitor your health, complete study procedures, and assess liver function.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed from Baseline up to study completion, which is about 224 weeks, to track the first occurrence of any major adverse liver outcome.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07165028

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~4,500 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:TirzepatideRetatrutidePlacebo

At a glance

Recruiting sites
481 of 563 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
Measured over Baseline up to Study Completion (about 224 weeks)
Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT07165028

Where you'd take part

This study runs at 563 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 4 Medical Solutions, Ltd - London

    London, United Kingdomstudy coordinator listed

    Recruiting

  • 4 Medical Solutions, Ltd - Manchester

    Clifton, United Kingdomstudy coordinator listed

    Recruiting

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Italystudy coordinator listed

    Recruiting

  • Abe Clinic

    Ōita, Japanstudy coordinator listed

    Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, United Kingdomstudy coordinator listed

    Recruiting

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, Turkey (Türkiye)study coordinator listed

    Not yet recruiting

  • Advanced Research Institute - Sandy

    Sandy City, Utahstudy coordinator listed

    Recruiting

  • Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Chinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Eligibility criteria

Inclusion

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

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
  • 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)

    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