drugset / Trial / NCT07335601

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

NCT07335601

Phase 2 Recruiting 120 enrolled Madrigal Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-12-29
Primary completion
2028-08
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Resmetirom Small molecule 80 mg
Comparator Resmetirom Small molecule 100 mg