Under construction – not a live service
Sign in
Taking peoplePhase 3

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.

Key facts

Who runs it
Eli Lilly and Company
Where
Linköping, SwedenSee the siteAlso in 33 other countries, 561 sites
Registry title
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Status
Recruiting
Phase
Phase 3
People taking part
4,500 people, planned
Started
15 Oct 2025
Expected to end
Aug 2032
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tirzepatide
  • Retatrutide
  • Placebo
Record updated
8 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Sweden

Also in 33 other countries, 561 sites

  • Universitetssjukhuset i LinkopingLinköping, SwedenContact: Mattias Ekstedt (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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

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.

The 4 groups in the trial

  • Tirzepatide (TZ01)Treatment being tested

    Participants will receive tirzepatide subcutaneously (SC)

    Treatment: Tirzepatide

  • Placebo (TZ01)Placebo, for comparison

    Participants will receive placebo SC

    Treatment: Placebo

  • Retatrutide (RT01)Treatment being tested

    Participants will receive retatrutide SC

    Treatment: Retatrutide

  • Placebo (RT01)Placebo, for comparison

    Participants will receive placebo SC

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests retatrutide and tirzepatide in adults with fatty liver disease at high riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 October 2026