Tests retatrutide and tirzepatide in adults with fatty liver disease at high risk
Tests retatrutide and tirzepatide in adults with fatty liver disease to prevent serious liver problems.
Plain-language title generated from the registry record
Registry title: A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Key facts
- Where
- Bad Oeynhausen, Berlin, Brandenburg, Dresden, Düsseldorf, Frankfurt, Hanover, Heidelberg, Homburg, Leipzig, Mainz, and Neuruppin, GermanySee the 13 sites
- Phase
- Phase 3
Where in Germany
- Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad OeynhausenBad Oeynhausen, GermanyTaking people
- Charité Campus Virchow-KlinikumBerlin, GermanyNot yet recruiting
- Universitätsklinikum Brandenburg an der HavelBrandenburg, GermanyNot yet recruiting
- Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet DresdenDresden, GermanyTaking people
- Deutsches Diabetes-Zentrum (DDZ)Düsseldorf, GermanyTaking people
- Universitätsklinikum Frankfurt Goethe-UniversitätFrankfurt, GermanyNot yet recruiting
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum HeidelbergHeidelberg, GermanyTaking people
- Universitaetsklinikum des SaarlandesHomburg, GermanyTaking people
- Eugastro GmbHLeipzig, GermanyTaking people
- Universitatsklinikum LeipzigLeipzig, GermanyTaking people
- Universitätsmedizin Johannes Gutenberg Universität MainzMainz, GermanyTaking people
- Ruppiner KlinikenNeuruppin, GermanyTaking people
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).