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Clinical Trials in the USA / NCT07335601
Recruiting Phase 2

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

NCT07335601 · tracked via the Priya Life Science USA tracker
Sponsor
Madrigal Pharmaceuticals, Inc.
Phase
Phase 2
Started
2025-12-29
Last updated
2026-08-26

Condition(s) studied

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Investigational drug(s) / intervention(s)

ResmetiromPlacebo

Resmetirom: Randomized 80 or 100 mg

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 9. Chronic rejection or chronic plasma-cell hepatitis. 10. Significant post-transplant vascular or biliary complications. 11. Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization. 12. Uncontrolled hypertension at screening or randomization. 13. Current hepatocellular carcinoma. 14. Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state. 15. Any serious medical condition with a life expectancy of less than 5 years. 16. Current substance abuse or drug addiction. 17. Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment. 18. Known hypersensitivity to study drug or any of its excipients. 19. 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. 20. Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization. 21. Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
University of California San Diego La Jolla California Recruiting
University of California Los Angeles Medical Center Los Angeles California Not Yet Recruiting
University of California, San Francisco San Francisco California Recruiting
University of Colorado Aurora Colorado Recruiting
Medstar Georgetown University Hospital Washington D.C. District of Columbia Not Yet Recruiting
Northwestern University Chicago Illinois Recruiting
The University of Chicago Medicine Chicago Illinois Not Yet Recruiting
Mayo Clinic Rochester Minnesota Recruiting
University of Nebraska Omaha Nebraska Not Yet Recruiting
Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset New York Recruiting
NY Presbyterian- Weill Cornell Medicine New York New York Recruiting
Vanderbilt University Medical Center (VUMC) Nashville Tennessee Recruiting
Dallas Methodist Dallas Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
University of Virginia Health System Charlottesville Virginia Recruiting
University Health Network - Toronto General Hospital (TGH) Toronto Ontario Not Yet Recruiting

More Madrigal Pharmaceuticals, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335601 on ClinicalTrials.gov ↗ ← All trials in the USA