RecruitingMASH - Metabolic Dysfunction-Associated Steatohepatitis

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Madrigal Pharmaceuticals, Inc.

You may qualify if…

✓ 1. At least 12 months post-liver transplant at screening and meeting one of the following:
✓ 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.

You may not qualify if…

✕ 1. Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
✕ 2. Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
✕ 3. FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
✕ 4. Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
✕ 5. Evidence of active liver disease other than MASH.
✕ 6. History of liver transplantation for an inborn error of metabolism.
✕ 7. Evidence of hepatic impairment or decompensation at screening.
✕ 8. Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.