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

Zusammenfassung

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.

Eignung

Studiendesign

Endpunkte

1. Primärer Endpunkt

   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

   Zeitrahmen Baseline up to Study Completion (about 224 weeks)

2. Sekundärer Endpunkt

   Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

   Zeitrahmen Baseline, Week 104

3. Sekundärer Endpunkt

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

   Zeitrahmen Baseline, Week 104

4. Sekundärer Endpunkt

   Percent Change from Baseline in Liver Fat Content (LFC)

   Zeitrahmen Baseline, Week 104

5. Sekundärer Endpunkt

   Time to Occurrence of Progression to Cirrhosis

   Zeitrahmen Baseline up to Study Completion (about 224 weeks)

6. Sekundärer Endpunkt

   Change from Baseline in Aspartate Aminotransferase (AST)

   Zeitrahmen Baseline, Study Completion (about 224 weeks)

7. Sekundärer Endpunkt

   Change from Baseline in Alanine Aminotransferase (ALT)

   Zeitrahmen Baseline, Study Completion (about 224 weeks)

8. Sekundärer Endpunkt

   Change from Baseline in Body Weight

   Zeitrahmen Baseline, Study Completion (about 224 weeks)

9. Sekundärer Endpunkt

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

   Zeitrahmen Baseline, Week 104

10. Sekundärer Endpunkt

    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

    Zeitrahmen Baseline up to Study Completion (about 224 weeks)

Daten

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

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Änderungen im Zeitverlauf

1. 8. September 2026

   Studienzentrum entfernt

   2 sites removed (563 total)

   565 → 563

2. 21. August 2026

   Studienzentrum hinzugefügt

   1 site added (565 total)

   564 → 565

3. 6. August 2026

   Studienzentrum hinzugefügt

   1 site added (564 total)

   563 → 564