Search > Fatty Liver Disease

Resmetirom for Fatty Liver Disease Post-Liver Transplant

Not currently recruiting at 14 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Madrigal Pharmaceuticals, Inc.
Must be taking: Immunosuppressants
Must not be taking: Statins, others
Disqualifiers: Alcohol use, Thyroid disease, HIV, others
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

TH

Tom Hare, MS

Principal Investigator

Madrigal Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for post-liver transplant patients with MASH-related fibrosis. Cohort 1 includes those who had a transplant due to MASH cirrhosis and have recurrent MASH, while Cohort 2 includes those transplanted for other reasons but developed new-onset MASH. Participants must have stable kidney function, liver enzymes, and immunosuppressive regimens; agree to use contraception if of childbearing potential; and not be pregnant or breastfeeding.

Inclusion Criteria

I had a liver transplant for MASH cirrhosis and now have a fat content of 8% or more in my liver.
I have a metabolic risk factor like being overweight or having high blood pressure.
I agree to use contraception and not donate sperm during and for 30 days after the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Resmetirom or placebo daily for 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Extension

Participants may continue to be monitored for long-term effects up to 52 weeks

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Resmetirom

Trial Overview

The study tests Resmetirom against a placebo in two groups of liver transplant recipients with moderate to advanced fibrosis from MASH. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), and placebo-controlled (compared with an inactive substance).

How Is the Trial Designed?

4

Treatment groups

Active Control

Placebo Group

Group I: Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1Active Control1 Intervention
Group II: Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2Active Control1 Intervention
Group III: Arm 3: Placebo - Cohort 1Placebo Group1 Intervention
Group IV: Arm 4: Placebo - Cohort 2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Madrigal Pharmaceuticals, Inc.

Lead Sponsor

Trials
16
Recruited
5,400+

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