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

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  Administered SC
• Retatrutide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Oct 15, 2025

Status verified

Jun 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2032

Study Design

Enrollment

4,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide (TZ01)
  Participants will receive tirzepatide subcutaneously (SC)
• Placebo Comparator: Placebo (TZ01)
  Participants will receive placebo SC
• Experimental: Retatrutide (RT01)
  Participants will receive retatrutide SC
• Placebo Comparator: Placebo (RT01)
  Participants will receive placebo SC

Primary Outcome Measure

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) [ Time Frame: Baseline up to Study Completion (about 224 weeks) ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (140)

Find similar trials in Tuscaloosa, AL

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