Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMadrigal Pharmaceuticals, Inc.
About this trial
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 criteria
Qualifiers
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
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.
MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.
Disqualifiers
Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa.
Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
Trial design
Treatments tested in this trial
- Resmetirom
- Placebo
Treatment groups
120 Participants
are divided into 4 treatment groupsLocations
17Canada
University Health Network - Toronto General Hospital (TGH)M5G 2C4, TorontoOntario, Canada
United States
California
University of California San Diego92037, La Jolla United States
University of California Los Angeles Medical Center90095, Los Angeles United States
University of California, San Francisco94143, San Francisco United States
Sponsors and collaborators
Madrigal Pharmaceuticals, Inc.
Lead sponsor
Source ClinicalTrials.gov