A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Recruiting now Phase 3 NCT07165028
Run by Eli Lilly and Company · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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 this trial is running
- 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
+ 549 more sites.
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07165028.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.