A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Key facts
- Where
- Calgary, Chicoutimi, Edmonton, Halifax, London, North Bay, Québec, Toronto, Trois-Rivières, Vancouver, and Winnipeg, CanadaSee the 15 sites
- Phase
- Phase 3
Where in Canada
- Heritage Medical Research ClinicCalgary, CanadaNot yet recruiting
- Ecogene-21Chicoutimi, CanadaTaking people
- University of Alberta HospitalEdmonton, CanadaNot yet recruiting
- Wells Research GroupEdmonton, CanadaTaking people
- QEII Health Sciences Centre, Victoria General SiteHalifax, CanadaNot yet recruiting
- University Hospital - London Health Sciences CentreLondon, CanadaTaking people
- Private Practice - Dr. Stephane M. GauthierNorth Bay, CanadaTaking people
- Diex Recherche QuébecQuébec, CanadaTaking people
- Clinical Research of OntarioToronto, CanadaTaking people
- St. Joseph's Health CentreToronto, CanadaNot yet recruiting
- Toronto General HospitalToronto, CanadaNot yet recruiting
- Diex Recherche Inc. Division Trois-RivieresTrois-Rivières, CanadaTaking people
- (G.I.R.I.) GI Research Institute FoundationVancouver, CanadaNot yet recruiting
- Vancouver General HospitalVancouver, CanadaNot yet recruiting
- Health Sciences Centre WinnipegWinnipeg, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07165028EU 2025-522674-36-00
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes
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.
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: 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 any other type of liver disease other than MASLD; Have type 1 diabetes; Have a hemoglobin A1c (HbA1c) greater than 10%; Have a body mass index (BMI) <25 kilogram per square meter (kg/m2).