Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies
Madrigal Pharmaceuticals, Inc.
Summary
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 12 months post-liver transplant at screening and meeting one of the following: * Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF * Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF 2. Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy. 3. MASH with moderate to advanced liver fibrosis (F2-F3),…
Interventions
- DrugResmetirom
Randomized 80 or 100 mg
- DrugPlacebo
Placebo
Locations (15)
- University of California San DiegoLa Jolla, California
- University of California Los Angeles Medical CenterLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- University of ColoradoAurora, Colorado
- Northwestern UniversityChicago, Illinois
- The University of Chicago MedicineChicago, Illinois