A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Li… (NCT07165028) | Clinical Trial Compass
RecruitingPhase 3
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
United States, Argentina, Australia4,500 participantsStarted 2025-10-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Have any other type of liver disease other than MASLD
* Have a body mass index (BMI) \<25 kilogram per square meter (kg/m2)
* 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 a hemoglobin A1c (HbA1c) greater than 10%
* Have type 1 diabetes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
Timeframe: Baseline up to Study Completion (about 224 weeks)
Trial details
NCT IDNCT07165028
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-08
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or