Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH (NCT07335601) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
United States120 participantsStarted 2025-12-29
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. At least 12 months post-liver transplant at screening and meeting one of the following:
✓. 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 4 weeks 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 30 days after the last dose; females not of childbearing potential are eligible.
✓. Sexually active males with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose and not donate sperm during this period.
Exclusion criteria
✕. Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
What they're measuring
1
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
✕. Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
✕. FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
✕. 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.
✕. 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.