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

ملخص

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.

الأهلية

تصميم الدراسة

مقاييس النتائج

1. مقياس النتيجة الأولي

   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

   الإطار الزمني Baseline up to Study Completion (about 224 weeks)

2. مقياس النتيجة الثانوي

   Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

   الإطار الزمني Baseline, Week 104

3. مقياس النتيجة الثانوي

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

   الإطار الزمني Baseline, Week 104

4. مقياس النتيجة الثانوي

   Percent Change from Baseline in Liver Fat Content (LFC)

   الإطار الزمني Baseline, Week 104

5. مقياس النتيجة الثانوي

   Time to Occurrence of Progression to Cirrhosis

   الإطار الزمني Baseline up to Study Completion (about 224 weeks)

6. مقياس النتيجة الثانوي

   Change from Baseline in Aspartate Aminotransferase (AST)

   الإطار الزمني Baseline, Study Completion (about 224 weeks)

7. مقياس النتيجة الثانوي

   Change from Baseline in Alanine Aminotransferase (ALT)

   الإطار الزمني Baseline, Study Completion (about 224 weeks)

8. مقياس النتيجة الثانوي

   Change from Baseline in Body Weight

   الإطار الزمني Baseline, Study Completion (about 224 weeks)

9. مقياس النتيجة الثانوي

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

   الإطار الزمني Baseline, Week 104

10. مقياس النتيجة الثانوي

    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

    الإطار الزمني Baseline up to Study Completion (about 224 weeks)

التواريخ

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

481 موقعاً قيد التجنيد

يُدرَج 513 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

1. 8 سبتمبر 2026

   أُزيل موقع

   2 sites removed (563 total)

   565 → 563

2. 21 أغسطس 2026

   أُضيف موقع

   1 site added (565 total)

   564 → 565

3. 6 أغسطس 2026

   أُضيف موقع

   1 site added (564 total)

   563 → 564