This study is not yet accepting patients

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

a study on Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Rohit Loomba (ucsd)
Headshot of Rohit Loomba
Rohit Loomba

Description

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.

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

Keywords

Metabolic Dysfunction-Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, NASH, Fatty Liver, Fatty Liver Disease, SLD, Metabolic Dysfunction-Associated Fatty Liver Disease, MAFLD, Non-alcoholic Fatty Liver Disease, NAFLD, Hepatic Steatosis, Liver Related Outcomes, GLP1, Incretin, Non-Invasive Test, Tirzepatide, retatrutide, Counterfeit Drugs, Tirzepatide (TZ01), Retatrutide (RT01)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
    La Jolla 5363943 California 5332921 92037 United States
  • Ark Clinical Research - Fountain Valley
    Fountain Valley 5350207 California 5332921 92708 United States
  • Fresno Clinical Research Center
    Fresno 5350937 California 5332921 93720 United States
  • San Fernando Valley Health Institute
    Canoga Park 5333913 California 5332921 91304 United States
  • California Liver Research Center
    Pasadena 5381396 California 5332921 91105 United States
  • Ark Clinical Research
    Long Beach 5367929 California 5332921 90815 United States

Lead Scientist at University of California Health

  • Rohit Loomba (ucsd)
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 300 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT07165028
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 4500 study participants
Last Updated