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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

"Study testing treatments for liver disease with metabolic issues."

Recruiting
18 years and older
All
Phase 3

The SYNERGY-OUTCOMES study is looking to see if two medicines, **retatrutide** and **tirzepatide**, can help prevent serious liver problems in adults with a condition called **metabolic dysfunction-associated steatotic liver disease (MASLD)**. This condition means there's too much fat in the liver, which can lead to more serious problems. Participants will be divided into groups: some will get one of the medicines, and others will receive a *placebo* (a pill with no medicine). There are about 4,500 adults in the study, which lasts around 4.3 years (224 weeks). Participants will need to visit the clinic 25 to 30 times for check-ups to see how their liver is doing.

After the study, there's an option to join an extra 2-year study where everyone will receive either retatrutide or tirzepatide. To join, you must have a certain amount of liver fat and other specific test results, but you can't have other liver diseases or certain health conditions like type 1 diabetes.

  • Study lasts around 4.3 years.
  • Requires 25 to 30 clinic visits.
  • Optional 2-year extension with active treatment.
Study details
    Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT07165028

Eli Lilly and Company

25 April 2026

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