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

NCT07165028

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions: Tirzepatide, Retatrutide, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (565)
  • Tuscaloosa, Alabama, United States
  • Chandler, Arizona, United States
  • Gilbert, Arizona, United States
  • Peoria, Arizona, United States
  • Sun City, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • North Little Rock, Arkansas, United States
  • Canoga Park, California, United States
  • Fountain Valley, California, United States
  • Fresno, California, United States
  • La Jolla, California, United States
  • Lake Forest, California, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Riverside, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Englewood, Colorado, United States
  • Hamden, Connecticut, United States
  • Clermont, Florida, United States
  • Daytona Beach, Florida, United States
  • Delray Beach, Florida, United States
  • Doral, Florida, United States
  • Fort Myers, Florida, United States
  • + 535 more on CT.gov