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

תקציר

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.

זכאות

תכנון המחקר

מדדי תוצאה

1. מדד תוצאה ראשוני

   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

   מסגרת זמן Baseline up to Study Completion (about 224 weeks)

2. מדד תוצאה משני

   Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

   מסגרת זמן Baseline, Week 104

3. מדד תוצאה משני

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

   מסגרת זמן Baseline, Week 104

4. מדד תוצאה משני

   Percent Change from Baseline in Liver Fat Content (LFC)

   מסגרת זמן Baseline, Week 104

5. מדד תוצאה משני

   Time to Occurrence of Progression to Cirrhosis

   מסגרת זמן Baseline up to Study Completion (about 224 weeks)

6. מדד תוצאה משני

   Change from Baseline in Aspartate Aminotransferase (AST)

   מסגרת זמן Baseline, Study Completion (about 224 weeks)

7. מדד תוצאה משני

   Change from Baseline in Alanine Aminotransferase (ALT)

   מסגרת זמן Baseline, Study Completion (about 224 weeks)

8. מדד תוצאה משני

   Change from Baseline in Body Weight

   מסגרת זמן Baseline, Study Completion (about 224 weeks)

9. מדד תוצאה משני

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

   מסגרת זמן Baseline, Week 104

10. מדד תוצאה משני

    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

    מסגרת זמן Baseline up to Study Completion (about 224 weeks)

תאריכים

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

481 אתרים מגייסים

513 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

1. 8 בספטמבר 2026

   אתר הוסר

   2 sites removed (563 total)

   565 → 563

2. 21 באוגוסט 2026

   אתר נוסף

   1 site added (565 total)

   564 → 565

3. 6 באוגוסט 2026

   אתר נוסף

   1 site added (564 total)

   563 → 564