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ACTIVE NOT RECRUITING
NCT07335601
PHASE2

Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH

Sponsor: Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

DRUG

Resmetirom

Randomized 80 or 100 mg

DRUG

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