🏛️ Verified NIH Record • Updated 2026-08-25

Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH (NCT07335601)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Madrigal Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (22 items).

Location: University of California San Diego — La Jolla, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
  • Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
  • FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
  • Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
  • Evidence of active liver disease other than MASH.
  • History of liver transplantation for an inborn error of metabolism.
  • Evidence of hepatic impairment or decompensation at screening.
  • 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.
  • Chronic rejection or chronic plasma-cell hepatitis.
  • Significant post-transplant vascular or biliary complications.
  • Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

  • University of California San Diego — La Jolla, California
  • University of California Los Angeles Medical Center — Los Angeles, California
  • University of California, San Francisco — San Francisco, California
  • University of Colorado — Aurora, Colorado
  • Medstar Georgetown University Hospital — Washington D.C., District of Columbia
  • Northwestern University — Chicago, Illinois
  • The University of Chicago Medicine — Chicago, Illinois
  • Mayo Clinic — Rochester, Minnesota
  • University of Nebraska — Omaha, Nebraska
  • Northwell Health Inc, Center for Liver Disease and Transplantation — Manhasset, New York
  • NY Presbyterian- Weill Cornell Medicine — New York, New York
  • Vanderbilt University Medical Center (VUMC) — Nashville, Tennessee
  • Dallas Methodist — Dallas, Texas
  • Houston Methodist Hospital — Houston, Texas
  • Intermountain Medical Center — Murray, Utah
  • University of Virginia Health System — Charlottesville, Virginia
  • University Health Network - Toronto General Hospital (TGH) — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (302) 640-2217

Email: dhernandez@madrigalpharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗