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Study of Resmetirom in Patients with Well-compensated Non-alcoholic Steatohepatitis (NASH) Cirrhosis to Evaluate Effects on Liver Health

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Non-alcoholic Steatohepatitis (NASH) with cirrhosis, a severe liver condition where fat accumulation leads to liver scarring. The study tests a medication called resmetirom, which is given as a film-coated tablet taken by mouth once daily. Patients will receive either resmetirom at doses of 60 mg, 80 mg, or 100 mg, or placebo.

The purpose of this research is to determine how effective resmetirom is in preventing serious liver-related complications in patients with well-compensated NASH cirrhosis. The study will track important health events including liver-related problems, need for liver transplant, and changes in liver function.

During the study, which lasts up to 36 months, participants will take their assigned medication daily. Throughout this period, they will have regular check-ups to monitor their liver health. Various measurements will be taken, including blood tests to check cholesterol levels and special imaging tests to measure the amount of fat in the liver. The study uses MRI-PDFF (magnetic resonance imaging) to measure changes in liver fat content.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    A medical assessment will confirm if you have well-compensated NASH cirrhosis (a type of liver disease).

    Various tests will be performed to verify your liver condition, including blood tests and imaging studies.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either resmetirom or a placebo (inactive tablet).

    The assignment will be done randomly, and neither you nor your doctor will know which treatment you are receiving.

  3. Step 3

    Daily medication

    You will take one tablet daily by mouth.

    The tablet will be either resmetirom (80 mg) or a matching placebo.

    This treatment will continue throughout the study period.

  4. Step 4

    Regular monitoring

    Your liver health will be regularly monitored through various tests.

    At week 28, your cholesterol levels will be checked.

    At week 52, if applicable, an imaging test will measure the amount of fat in your liver.

  5. Step 5

    Long-term follow-up

    The study will continue until 2026.

    During this time, your liver health will be monitored for any significant changes or complications.

    The main focus will be on tracking any liver-related events or changes in your liver condition.

Who can join the trial?

11 criteria

  • Must be willing to participate and provide written informed consent
  • Must be at least 18 years of age, both men and women can participate
  • Female participants must either:
    • Be able to have children and have a negative pregnancy test, not be pregnant or breastfeeding, and use effective birth control during the study and for 30 days after
    • Or be unable to have children due to surgery or natural causes (no menstrual periods for over 12 months)
    • Male participants who are sexually active must either:
      • Be unable to father children (proven by vasectomy)
      • Practice complete sexual abstinence
      • Use birth control during the study and for 30 days after
      • Must have confirmed NASH cirrhosis (a severe liver condition) proven by either:
        • Liver biopsy results
        • Special imaging tests showing liver scarring
        • Blood test results indicating liver damage
        • Must have well-controlled liver disease (Child-Pugh A score between 5-6) with no history of liver complications

Who cannot join the trial?

14 criteria

  • Age below 18 years
  • Presence of alcoholic liver disease (liver damage caused by alcohol consumption)
  • History of liver transplantation
  • Current hepatic encephalopathy (confusion and altered mental state due to liver problems)
  • Active variceal bleeding (bleeding from enlarged veins in the esophagus)
  • Presence of ascites (fluid accumulation in the abdomen) that requires regular drainage
  • MELD score (Model for End-stage Liver Disease score) greater than or equal to 15
  • Presence of liver cancer or other types of cancer
  • Severe heart or kidney disease
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Use of medications that could interact with the study drug
  • Inability to provide informed consent
  • History of poor compliance with medical treatments
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Investigated drugs

Resmetirom is an oral medication taken once daily that works by targeting thyroid hormone receptors in the liver. It is being studied for treating non-alcoholic steatohepatitis (NASH) with cirrhosis. This medication aims to improve liver function and prevent complications in patients with liver disease. It may help reduce liver-related health issues and cardiovascular problems in patients with NASH cirrhosis.

What is already known about the treatment

Resmetirom - An oral medication administered once daily in 80 mg tablets, specifically designed for treating Non-alcoholic Steatohepatitis (NASH) with cirrhosis. This investigational drug works by acting as a thyroid hormone receptor beta agonist, selectively targeting liver cells to reduce fat accumulation and inflammation in the liver without affecting other body tissues. Currently undergoing Phase 3 clinical trials, Resmetirom shows promise in preventing liver-related complications and cardiovascular events in patients with well-compensated NASH cirrhosis, representing a potential breakthrough in treating this serious liver condition that currently has limited treatment options.

Investigated diseases

  • Non-alcoholic Steatohepatitis (NASH)

    A progressive liver disease characterized by fat accumulation in the liver accompanied by inflammation and cell damage. The condition develops when excess fat builds up in liver cells, leading to inflammation and eventually scarring of liver tissue. NASH can progress slowly over years, causing the liver to become enlarged and less functional. The disease typically shows no symptoms in its early stages but may cause fatigue and pain in the upper right abdomen as it advances. When NASH progresses significantly, it can lead to cirrhosis, where healthy liver tissue is replaced by scar tissue.

  • Cirrhosis

    A chronic liver condition characterized by extensive scarring of liver tissue that develops when healthy liver cells are gradually replaced by scar tissue. This scarring process, called fibrosis, occurs as the liver tries to repair and replace damaged cells. As cirrhosis progresses, the liver becomes increasingly hardened and lumpy, making it more difficult for the organ to function properly. The condition develops slowly over many years and can be caused by various factors or diseases affecting the liver.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510627-20-00Protocol codeMGL-3196-19Estimated enrolment845 patientsSponsorMadrigal Pharmaceuticals Inc.

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