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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Randomized 80 or 100 mg
Placebo
University of California San Diego
La Jolla, California, United States
University of California Los Angeles Medical Center
Los Angeles, California, United States
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
Time frame: 28 weeks
To evaluate the safety and tolerability of once-daily, oral administration of MGL-3196/resmetirom versus matching placebo in patients who have undergone a liver transplant
Time frame: 52 weeks
1.To determine the effect of MGL-3196/resmetirom versus matching placebo on liver stiffness as measured by FibroScan vibration controlled transient elastography (VCTE; kPa)
Absolute change and percent change from Baseline to Week 28 and Week 52 on FibroScan VCTE
Time frame: 28 and 52 Weeks
2. To determine the effect of MGL-3196/resmetirom versus matching placebo on serum lipid parameters
Absolute and percent change from Baseline to Week 28 and Week 52 in LDL-C, lipoprotein A \[Lp(a)\] in patients with baseline Lp(a) \>10 nmol/L and triglycerides (TGs) in patients with baseline TGs \>150 mg/dL
Time frame: 28 and 52 Weeks
3. To determine the effect of MGL-3196/resmetirom versus matching placebo on liver biochemistries
Absolute and percent change from baseline in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma glutamyl transferase (GGT), at Week 28 and Week 52
Time frame: 28 and 52 weeks
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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
...and 5 more locations