A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease
In brief
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.
Key facts
- Study ID
- NCT07165028
- Run by
- Eli Lilly and Company
- People needed
- 4500
- Starts
- 2025-10-15
- Expected to finish
- 2032-08-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- The Institute for Liver Health II dba Arizona Clinical Trials - Chandler — Chandler, Arizona, United States (enrolling)
- Spectrum Research Institute — Gilbert, Arizona, United States (enrolling)
- The Institute for Liver Health II dba Arizona Liver Health - Peoria — Peoria, Arizona, United States (enrolling)
- Epic Medical Research-Sun City — Sun City, Arizona, United States (enrolling)
- The Institute for Liver Health II dba Arizona Clinical Trials - Tucson — Tucson, Arizona, United States (enrolling)
- Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
- Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas, United States (enrolling)
- San Fernando Valley Health Institute — Canoga Park, California, United States (enrolling)
- Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States (enrolling)
- Fresno Clinical Research Center — Fresno, California, United States (enrolling)
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States (enrolling)
- Orange County Research Center — Lake Forest, California, United States (enrolling)
- Om Research LLC — Lancaster, California, United States (enrolling)
- Ark Clinical Research — Long Beach, California, United States (enrolling)
- Los Angeles Institute for Metabolic Research — Los Angeles, California, United States (enrolling)
- United Medical Doctors - Murrieta — Murrieta, California, United States (enrolling)
- Knowledge Research Center — Orange, California, United States (enrolling)
- California Liver Research Center — Pasadena, California, United States (enrolling)
- Artemis Institute for Clinical Research — Riverside, California, United States (enrolling)
- Medical Associates Research Group — San Diego, California, United States (enrolling)
- Quest Clinical Research — San Francisco, California, United States (enrolling)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- South Denver Gastroenterology — Englewood, Colorado, United States (enrolling)
- Medical Research Center of Connecticut — Hamden, Connecticut, United States (enrolling)
- MFA Clinical Research — Tuscaloosa, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.