N1T-MC-MALO
Research type
Research Study
Full title
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 (SYNERGY-Outcomes)
IRAS ID
1012805
Contact name
Maryna Kvochka
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
The SYNERGY OUTCOMES study will evaluate whether two study drugs (retatrutide and tirzepatide) can prevent major adverse liver outcomes (MALO) in people with high-risk Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
The study is divided into two sub-studies. In each sub-study the participants will receive an active study drug (tirzepatide or retatrutide) or a placebo (a substance with no active drug). The study will enrol adults who have MASLD based on non-invasive tests (NITs), eligible participants will then be randomly assigned to one of the sub-studies. Within each sub-study, participants will be randomly assigned to receive either the active study drug or a placebo. Twice as many people will receive the active study drug as the placebo.
The study population will be adults with MASLD who are at higher risk of developing serious liver disease and between 35% and 65% of participants are expected to have type 2 diabetes. Patient participation is expected to last up to 5 years, but this may be shorter or longer depending on when the study ends. Upon completion of the study, eligible participants may join an optional 2-year extension study, where all will receive either retatrutide or tirzepatide depending on the sub-study they were initially assigned to.
Approximately 4500 people will be enrolled in the study globally, including approximately 120 participants from the UK.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0344
Date of REC Opinion
14 Nov 2025
REC opinion
Further Information Favourable Opinion