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
- Ivano-Frankivsk, Kiev, Kyiv, Lviv, Vinnytsia, and Zhytomyr, UkraineSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a fatty liver disease called MASLD who are at higher risk of serious liver problems, based on non-invasive liver tests.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- MASLD with liver fat content ≥8%, ELF score of ≥9 and ≤10.8 at screening, and VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening
- Biomarker or test result
- Liver fat content ≥8%; ELF score of ≥9 and ≤10.8; VCTE LSM ≥10 kPa and <20 kPa
Main reasons for not taking part
- Any other type of liver disease besides MASLD
- Body mass index (BMI) <25 kg/m2
- Earlier decompensated liver disease (varices, ascites, hepatic encephalopathy)
- Weight loss of more than 11 pounds (5 kg) in the 3 months before screening
- Hemoglobin A1c (HbA1c) greater than 10% (86 mmol/mol), or type 1 diabetes
Read by machine on 12 November 2026.
Where in Ukraine
- Clinical Diagnostic CenterIvano-Frankivsk, UkraineContact: Vadym Berenfus (principal investigator)Taking people
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"Kiev, UkraineContact: Oksana Gerasymenko (principal investigator)Taking people
- Center of Family Medicine PlusKyiv, UkraineContact: Liudmyla Chupryna (principal investigator)Taking people
- Edelweiss MedicsKyiv, UkraineContact: Oleksandra Tymofeieva (principal investigator)Taking people
- Medbud ClinicKyiv, UkraineContact: Svitlana Postol (principal investigator)Taking people
- Medical Center OK!Clinic+Kyiv, UkraineContact: Nataliia Tsarynna (principal investigator)Taking people
- Progastro ClinicLviv, UkraineContact: Olha Ivanishyn (principal investigator)Taking people
- Limited liability company "Medical center Health Clinic"Vinnytsia, UkraineContact: Oleksandr Golovchenko (principal investigator)Taking people
- Medical Center SalutemVinnytsia, UkraineContact: Oksana Nyzkoshapka (principal investigator)Taking people
- Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -TVinnytsia, UkraineContact: Mykola Stanislavchuk (principal investigator)Taking people
- CRZ VidnovlennyaZhytomyr, UkraineContact: Tetiana Bevz (principal investigator)Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).