RecruitingPHASE2INTERVENTIONAL

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

This research trial is testing a new medication called Resmetirom for people who have received a liver transplant and have since developed a liver condition called MASH. MASH, or Metabolic Dysfunction-Associated Steatohepatitis, is a serious type of fatty liver disease. The study is comparing Resmetirom to a dummy pill (placebo) to see if it can help improve liver problems in two groups of transplant patients: those who had their original transplant because of MASH and now have it again, and those who had a transplant for a different reason and have now developed MASH for the first time. Participants will be aged 18 to 75. This is a Phase 2 study, meaning it's still in the earlier stages of research.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Madrigal Pharmaceuticals, Inc.

Enrolment target

120

Start

29 Dec 2025

Estimated completion

01 Mar 2029

MASH - Metabolic Dysfunction-Associated Steatohepatitis

What is this study about?

This study is about a liver condition called MASH. Most people know about fatty liver disease, but MASH is a more serious form where there's not only fat but also swelling and damage in the liver. Over time, this can lead to scarring, known as fibrosis. For some people, MASH can become so severe that they need a liver transplant.

Even after a successful liver transplant, MASH can sometimes come back, or it can develop for the first time in people who had a transplant for a different reason. This study is testing a new medicine, called Resmetirom, to see if it can help these patients. The hope is that Resmetirom might reduce the liver fat and damage in people who have had a transplant and are now dealing with MASH again.

Researchers want to find out if Resmetirom is safe and effective in this specific group of patients. They will compare it to a 'placebo', which is a dummy pill with no active medicine. This helps them understand whether any changes seen are truly due to the medicine or something else. Understanding how Resmetirom works in transplant patients with MASH is a really important step in finding better treatments.

Key takeaways

This study is for liver transplant patients with MASH.
It tests a new medicine called Resmetirom against a dummy pill (placebo).
It aims to see if Resmetirom can improve MASH in transplant patients.
You must have had your transplant at least one year ago and have confirmed MASH.
Involves regular clinic visits, tests, and potentially liver biopsies.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be between 18 and 75 years old and have had a liver transplant at least a year ago. You must also have MASH. This means you'll have extra fat in your liver, which doctors will measure with special scans, and some scarring in your liver (fibrosis) that a liver biopsy has confirmed is at a moderate or advanced stage (F2 or F3).

You might be eligible if your original transplant was because of MASH and it has now returned, or if you had a transplant for another reason and have now developed MASH for the first time. You also need to have at least one health factor linked to MASH, like being overweight, having high blood pressure, or having high cholesterol or blood sugar issues.

There are also some reasons why you might not be able to join. For example, if you've recently taken part in another clinical trial with a new medication, or if you have a history of significant alcohol use. People with certain severe liver problems other than MASH, uncontrolled thyroid issues, or very poor kidney function would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Did you have a liver transplant at least 12 months ago?
Do you have MASH with moderate to advanced liver scarring (F2/F3)?
Have your regular anti-rejection medicines been stable for at least 3 months?
Are you able to attend regular clinic visits and have tests?
Have you not recently taken part in another clinical trial with a new drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the study medicine, Resmetirom, or a placebo (a dummy pill). You and your doctors wouldn't know which one you're receiving. This is a "double-blind" study. You'd need to attend regular clinic visits where doctors would check your health, do blood tests, and liver scans (like FibroScan or MRE) periodically. Some participants would also have liver biopsies to check on the MASH. You'd be on your regular anti-rejection medicines, which need to be stable for at least 3 months before starting the study. The study would involve taking the assigned medication as prescribed, and you'd be carefully monitored throughout. The total duration of your participation would be explained fully by the study team, including any follow-up visits after you stop taking the study drug.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment, Resmetirom, which might help improve your MASH. However, as with all new medicines, there's no guarantee it will work for you, and there could be side effects or risks that aren't fully known yet. You might also receive the placebo, which means you wouldn't be getting the active drug. The study will involve various tests, including blood draws and potentially liver biopsies, which have their own small risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

University of California San Diego
Verified postcode
La Jolla, United States· Not yet recruiting
University of California Los Angeles Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
University of Colorado
Verified postcode
Aurora, United States· Not yet recruiting
Medstar Georgetown University Hospital
Verified postcode
Washington D.C., United States· Not yet recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
The University of Chicago Medicine
Verified postcode
Chicago, United States· Not yet recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Not yet recruiting
University of Nebraska
Verified postcode
Omaha, United States· Not yet recruiting
Northwell Health Inc, Center for Liver Disease and Transplantation
Verified postcode
Manhasset, United States· Not yet recruiting
New York Presbyterian Hospital
Verified postcode
New York, United States· Not yet recruiting
Vanderbilt University Medical Center (VUMC)
Verified postcode
Nashville, United States· Not yet recruiting

Common questions

What is MASH?

MASH is a serious type of fatty liver disease where there's not only fat, but also swelling and damage in the liver tissue.

What is a placebo?

A placebo is a dummy pill that looks like the study drug but contains no active medicine. It helps researchers see if the real medicine is having an effect.

Do I need a liver biopsy?

Yes, to be eligible, your MASH and level of liver scarring (fibrosis) must be confirmed by a recent liver biopsy.

Can I still take my usual medicines?

Yes, you would continue your regular medicines, including anti-rejection drugs, but they need to have been stable for at least 3 months.

How long will the study last?

The total length of time you'd be involved in the study, including taking the medication and follow-up visits, would be explained by the study team.

How to find out more

David Hernandez, MD

dhernandez@madrigalpharma.com 302-640-2217 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.