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
- A Coruña, Badalona, Barcelona, Ferrol, Huelva, Madrid, Palma, Pontevedra, Santander, Seville, and Valencia, SpainSee the 13 sites
- Phase
- Phase 3
Where in Spain
- CHUAC-Complejo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital NavalFerrol, SpainTaking people
- Hospital Infanta ElenaHuelva, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitari Son EspasesPalma, SpainTaking people
- CHOP - Hospital Universitario MonteceloPontevedra, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
- Hospital Clínico de ValenciaValencia, SpainTaking people
- Hospital Universitari i Politécnic La FeValencia, SpainTaking 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).