NCT07335601

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Madrigal Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

Type	Name	Description
DRUG	Resmetirom	Randomized 80 or 100 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study