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

StatusRecruiting
PhasePhase 2
Started2025-12-29
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 17 sites
2026-07-30
minor
Study Status, Contacts/Locations v4
Study sites17 entries, revised
New YorkNY Presbyterian- HospitalWeill Cornell Medicine
2026-06-12
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 17 sites
2026-05-27
critical
Study Status, Eligibility, Contacts/Locations v2
Primary completion pushed: 2027-07 → 2028-08
Completion pushed: 2027-12 → 2029-03
Study sites15→17
Eligibility criteria-188 characters
[...] rical values. Stable immunosuppressive regimen for at least 43 weeksmonths prior to screening. Females of childbearing potential must [...] ree to use effective contraception during the study and for at least 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 [...]
2026-04-29
notable
Study Status, Contacts/Locations v1
Trial status changed: Active, Not Recruiting → Recruiting
Study sitesdetails revised at 15 of 15 sites
2026-01-09
minor
Original filing
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.
Trial Details
NCT Number NCT07335601
Lead Sponsor Madrigal Pharmaceuticals, Inc.
Conditions MASH - Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 120 participants
Start Date 2025-12-29
Primary Completion 2028-08 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-26