Actively Recruiting
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Led by Madrigal Pharmaceuticals, Inc. · Updated on 2026-04-30
120
Participants Needed
15
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 12 months post-liver transplant at screening
- Liver transplant for MASH cirrhosis with recurrent hepatic steatosis 58% by MRI-PDFF (Cohort 1)
- Liver transplant for non-MASH cause with new hepatic steatosis 58% by MRI-PDFF (Cohort 2)
- Presence of at least one metabolic risk factor: overweight/obesity, dysglycemia or type 2 diabetes, hypertension, hypertriglyceridemia or low HDL cholesterol, or use of lipid-lowering therapy
- Moderate to advanced liver fibrosis (F2-F3) confirmed by noninvasive tests and liver biopsy consistent with Stage F2/F3 MASH
- Stable kidney function with eGFR 30 mL/min/1.73 m2 before and during screening
- Stable liver enzymes at screening without significant worsening
- Stable immunosuppressive treatment for at least 4 weeks before screening
- Females of childbearing potential must have negative pregnancy test, not breastfeed, and agree to use contraception during study and 30 days after last dose
- Females not of childbearing potential are eligible
- Sexually active males with partners of childbearing potential must use contraception during study and 30 days after last dose and not donate sperm during this period
You will not qualify if you...
- Participation in another investigational drug trial within 30 days prior to screening
- Phosphatidylethanol (PEth) value 20 ng/mL at screening or significant alcohol use within 1 year prior
- FibroScan VCTE >20 kPa, biopsy showing F4 fibrosis, or MRE >5 kPa
- Uncontrolled or significant thyroid disease
- Active liver disease other than MASH
- History of liver transplant for inborn metabolic error
- Evidence of hepatic impairment or decompensation at screening
- Steroid resistant rejection or rejection treated with high-dose steroids within 3 months prior
- Chronic rejection or plasma-cell hepatitis
- Significant vascular or biliary complications after transplant
- Significant heart or brain vessel disease within 6 months before randomization
- Uncontrolled high blood pressure at screening or randomization
- Current liver cancer
- Known HIV infection or significant immunocompromised state
- Serious medical condition with life expectancy under 5 years
- Current substance abuse or drug addiction
- Significant psychiatric, cognitive, or social issues interfering with participation
- Known allergy to study drug or excipients
- Use of prohibited medications affecting liver or thyroid function or unstable metabolic therapy doses
- Use of statins above allowed doses or unstable lipid-lowering therapy
- Contraindications to MRI such as incompatible implants, severe claustrophobia, or inability to undergo MRI procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
University of California San Diego
La Jolla, California, United States, 92037
Not Yet Recruiting
2
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60208
Actively Recruiting
6
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Not Yet Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
8
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, United States, 11030
Not Yet Recruiting
9
New York Presbyterian Hospital
New York, New York, United States, 10065
Not Yet Recruiting
10
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States, 37212
Not Yet Recruiting
11
Dallas Methodist
Dallas, Texas, United States, 75203
Not Yet Recruiting
12
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
13
Intermountain Medical Center
Murray, Utah, United States, 84107
Not Yet Recruiting
14
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
15
University Health Network - Toronto General Hospital (TGH)
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
Research Team
D
David Hernandez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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