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

Trial details

Who runs it

Madrigal Pharmaceuticals, Inc.

Trial code

NCT07335601

Record updated

26 August 2026

Original description

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.Read full original descriptionShow less

Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies

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.

Inclusion: 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; 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; Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening; Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values; Stable immunosuppressive regimen for at least 3 months prior to screening; 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.

Exclusion: 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; 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; Significant post-transplant vascular or biliary complications; Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization; Current substance abuse or drug addiction; Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization; Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization; Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism; Evidence of active liver disease other than MASH; History of liver transplantation for an inborn error of metabolism; Evidence of hepatic impairment or decompensation at screening; Chronic rejection or chronic plasma-cell hepatitis; Uncontrolled hypertension at screening or randomization; Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state; Any serious medical condition with a life expectancy of less than 5 years; Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment; Known hypersensitivity to study drug or any of its excipients; FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa; Current hepatocellular carcinoma; Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.

ClinicalTrials.gov NCT07335601