Testing retatrutide and tirzepatide to prevent serious liver complications in adults with high‑risk MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SYNERGY‑Outcomes is a randomized, phase 3 master protocol that assigns adults with high‑risk MASLD by noninvasive tests to retatrutide, tirzepatide, or placebo. The study plans to enroll about 4,500 participants and follow them for roughly 224 weeks with around 25–30 clinic visits to monitor liver function and clinical events. Key entry criteria use liver fat, ELF score, and VCTE liver stiffness to select people at higher risk of major adverse liver outcomes. After the main study, eligible participants may join an optional two‑year extension during which all participants can receive retatrutide or tirzepatide.

Why it matters

Who can join: the full rules

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

Where it's running

• MFA Clinical Research
  Tuscaloosa, Alabama, United States Recruiting
• The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
  Chandler, Arizona, United States Recruiting
• Spectrum Research Institute
  Gilbert, Arizona, United States Recruiting
• The Institute for Liver Health II dba Arizona Liver Health - Peoria
  Peoria, Arizona, United States Recruiting
• Epic Medical Research-Sun City
  Sun City, Arizona, United States Recruiting
• The Institute for Liver Health II dba Arizona Clinical Trials - Tucson
  Tucson, Arizona, United States Recruiting

+513 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.