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Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-29
Completion Date
2027-12
Last Updated
2026-01-13
Healthy Volunteers
No
Interventions
Resmetirom
Randomized 80 or 100 mg
Placebo
Placebo
Locations (15)
University of California San Diego
La Jolla, California, United States
University of California Los Angeles Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States
Dallas Methodist
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University Health Network - Toronto General Hospital (TGH)
Toronto, Ontario, Canada