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

Sintesi

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.

Idoneità

Disegno dello studio

Esiti misurati

1. Esito primario

   Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)

   Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality

   Orizzonte temporale Baseline up to Study Completion (about 224 weeks)

2. Esito secondario

   Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

   Orizzonte temporale Baseline, Week 104

3. Esito secondario

   Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)

   Orizzonte temporale Baseline, Week 104

4. Esito secondario

   Percent Change from Baseline in Liver Fat Content (LFC)

   Orizzonte temporale Baseline, Week 104

5. Esito secondario

   Time to Occurrence of Progression to Cirrhosis

   Orizzonte temporale Baseline up to Study Completion (about 224 weeks)

6. Esito secondario

   Change from Baseline in Aspartate Aminotransferase (AST)

   Orizzonte temporale Baseline, Study Completion (about 224 weeks)

7. Esito secondario

   Change from Baseline in Alanine Aminotransferase (ALT)

   Orizzonte temporale Baseline, Study Completion (about 224 weeks)

8. Esito secondario

   Change from Baseline in Body Weight

   Orizzonte temporale Baseline, Study Completion (about 224 weeks)

9. Esito secondario

   Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK)

   Orizzonte temporale Baseline, Week 104

10. Esito secondario

    Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)

    MACE-3 composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death

    Orizzonte temporale Baseline up to Study Completion (about 224 weeks)

Date

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

481 centri stanno reclutando

Nella scheda del registro sono indicati altri 513 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

1. 8 settembre 2026

   Centro rimosso

   2 sites removed (563 total)

   565 → 563

2. 21 agosto 2026

   Centro aggiunto

   1 site added (565 total)

   564 → 565

3. 6 agosto 2026

   Centro aggiunto

   1 site added (564 total)

   563 → 564