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NCT07335601 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
A Phase 2 study of MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Madrigal Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 15
- Study locations
NCT07335601: Active Phase 2 study of MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Madrigal Pharmaceuticals.
NCT07335601 is a Phase 2 study of MASH - Metabolic Dysfunction-Associated Steatohepatitis that is active but no longer recruiting, run by Madrigal Pharmaceuticals. The registered enrollment target is 120 participants, below the 448-participant average among 3 other MASH - Metabolic Dysfunction-Associated Steatohepatitis trials with a reported enrollment target (73% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07335601, a Phase 2 study of MASH - Metabolic Dysfunction-Associated Steatohepatitis, is active but no longer recruiting, sponsored by Madrigal Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Resmetirom
Study Locations (15)
California
- University of California San Diego - La Jolla
- University of California Los Angeles Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
Illinois
- Northwestern University - Chicago
- The University of Chicago Medicine - Chicago
New York
- Northwell Health Inc, Center for Liver Disease and Transplantation - Manhasset
- New York Presbyterian Hospital - New York
Texas
- Dallas Methodist - Dallas
- Houston Methodist Hospital - Houston
Colorado
- University of Colorado - Aurora
Minnesota
- Mayo Clinic - Rochester
Tennessee
- Vanderbilt University Medical Center (VUMC) - Nashville
Utah
- Intermountain Medical Center - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-12-29 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT07335601 still lists
NCT07335601 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 448-participant average among 3 other MASH - Metabolic Dysfunction-Associated Steatohepatitis trials with a reported enrollment target (73% lower).
The record links to 1 condition, with MASH - Metabolic Dysfunction-Associated Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07335601 lists 15 locations in 10 states (California, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT07335601 about?
NCT07335601 is a clinical study titled "Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH". 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 MA...
What is the current status of trial NCT07335601?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-12-29. Estimated completion is 2027-12.
What conditions does trial NCT07335601 study?
This clinical trial studies the following conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis.
What interventions are being tested in trial NCT07335601?
The interventions under investigation include: Placebo (DRUG), Resmetirom (DRUG).
Who is sponsoring clinical trial NCT07335601?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07335601 being conducted?
This trial has 15 study locations across California, Colorado, Illinois, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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