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Resmetirom for MASH After Liver Transplant

This study is testing a drug called resmetirom in people who have had a liver transplant and now have MASH (Metabolic Dysfunction-Associated Steatohepatitis), a type of fatty liver disease. You might be able to join if you are between 18 and 75 years old and had a liver transplant at least 12 months ago. This includes people who had a transplant for MASH that has returned, or people who had a transplant for other reasons and now have MASH. The study will look at how much liver fat changes after 28 weeks of treatment. The current status of the study is unclear.

Study design
This is a Phase 2, double-blind, randomized, placebo-controlled study involving about 120 participants. Participants will receive either resmetirom (80 or 100 mg) or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 28, which suggests follow-up for at least 28 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335601

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Madrigal Pharmaceuticals, Inc.
~120 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:ResmetiromPlacebo

At a glance

Recruiting sites
12 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
Measured over 28 weeks

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Explore related trials

CirrhosisLiver TransplantationNonalcoholic Steatohepatitis

Where it's being run

17 sites across 12 states
California3
Illinois2
New York2
Texas2
Colorado1
District of Columbia1
Minnesota1
Nebraska1

Study leadership

  • Tom Hare, MS · STUDY_DIRECTOR · Madrigal Pharmaceuticals, Inc.

Who to contact

David Hernandez, MD
[email protected]
302-640-2217
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 2. 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. 3. 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. 4. Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening. 5. Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values. 6. Stable immunosuppressive regimen for at least 3 months prior to screening. 7. Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible.

What this trial measures

  • Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 2828 weeks

    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%.