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New drug targets fatty liver in transplant patients

NCT ID NCT07335601

Disease control Sponsor: Madrigal Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study tests whether resmetirom, a daily pill, can reduce liver fat in people who have had a liver transplant and developed MASH (a type of fatty liver disease). About 120 participants will be randomly assigned to receive either resmetirom or a placebo for 28 weeks. The main goal is to see if the drug lowers liver fat as measured by MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Resmetirom (MGL-3196)
What this could lead to
If successful, this could offer a treatment to reduce liver fat and prevent further liver damage in transplant patients with MASH.
What could go wrong
This is an early Phase 2 trial with only 120 participants. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 12 months post-liver transplant at screening and meeting one of the following: * Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF * Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF 2. Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy. 3. MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection. 4. Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening. 5. Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values. 6. Stable immunosuppressive regimen for at least 3 months prior to screening. 7. Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible. Exclusion Criteria: 1. Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening. 2. Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening. 3. FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa. 4. Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism. 5. Evidence of active liver disease other than MASH. 6. History of liver transplantation for an inborn error of metabolism. 7. Evidence of hepatic impairment or decompensation at screening. 8. 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. 9. Chronic rejection or chronic plasma-cell hepatitis. 10. Significant post-transplant vascular or biliary complications. 11. Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization. 12. Uncontrolled hypertension at screening or randomization. 13. Current hepatocellular carcinoma. 14. Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state. 15. Any serious medical condition with a life expectancy of less than 5 years. 16. Current substance abuse or drug addiction. 17. Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment. 18. Known hypersensitivity to study drug or any of its excipients. 19. Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization. 20. Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization. 21. Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.

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Conditions

The condition(s) this trial relates to.

Fibrosis metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mash - metabolic dysfunction-associated steatohepatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dallas Methodist

    RECRUITING

    Dallas, Texas, 75203, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medstar Georgetown University Hospital

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • NY Presbyterian- Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Northwell Health Inc, Center for Liver Disease and Transplantation

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60208, United States

  • The University of Chicago Medicine

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University Health Network - Toronto General Hospital (TGH)

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of California Los Angeles Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Nebraska

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68198-2000, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University Medical Center (VUMC)

    RECRUITING

    Nashville, Tennessee, 37212, United States

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