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Study of resmetirom (MGL-3196) in patients with Non-Alcoholic Steatohepatitis (NASH) to prevent liver damage and disease progression

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What is this trial about?

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

This study examines the effectiveness of resmetirom (also known as MGL-3196) in treating people with Non-Alcoholic Steatohepatitis (NASH), a serious liver condition where fat buildup leads to inflammation and liver damage. NASH occurs when the liver becomes inflamed due to fat accumulation, which can lead to scarring of liver tissue (known as fibrosis) and potentially progress to more severe liver damage.

The study medication resmetirom is taken as a film-coated tablet by mouth once daily. Participants will receive either resmetirom at doses of 60 mg, 80 mg, or 100 mg, or a placebo. The study aims to determine if resmetirom can help resolve NASH and prevent the progression of liver damage. The treatment period lasts for approximately 54 months, during which participants will have regular check-ups to monitor their liver health.

Throughout the study, doctors will use various methods to assess how well the treatment is working, including examining liver tissue samples and using specialized imaging called MRI-PDFF to measure liver fat content. They will also monitor the levels of various substances in the blood that can indicate liver health and track any changes in LDL cholesterol levels. After the main study period, some participants may have the opportunity to continue treatment in a long-term extension phase.

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 assessment and medication start

    After joining the study, you will receive either resmetirom or a placebo (inactive tablet that looks the same)

    The medication will be taken once daily by mouth in one of these doses: 60 mg, 80 mg, or 100 mg

    You will need to have an MRI scan to measure liver fat content

    A liver biopsy (small tissue sample from liver) will be performed to assess your condition

  2. Step 2

    Week 24 evaluation

    Your blood will be tested to measure LDL cholesterol levels

    The medical team will evaluate how your body is responding to the treatment

  3. Step 3

    Week 52 evaluation

    Another evaluation of your LDL cholesterol will be performed

    A second liver biopsy will be done to check if your liver condition has improved

    The medical team will look for improvements in liver inflammation and scarring

  4. Step 4

    Long-term follow-up to month 54

    You will continue taking the study medication

    Regular health assessments will monitor your liver condition

    A final liver biopsy will be performed at month 54

  5. Step 5

    Optional extension phase

    If you complete all previous study visits and the month 54 liver biopsy, you may be eligible to continue in an extension phase

    The extension phase will help gather additional long-term safety information

    Treatment will continue beyond 54 months

Who can join the trial?

7 criteria

  • Must be willing to provide written informed consent to participate in the study
  • Must be 18 years or older
  • For women who can become pregnant: - Must have a negative pregnancy test - Must not be breastfeeding - Must use two highly effective birth control methods during the study and for 30 days after - Or must be post-menopausal (no periods for 12 months) or permanently sterile
  • For men who are sexually active: - Must be sterile, or - Practice complete sexual abstinence, or - Use condoms during sexual activity - Must use birth control during the study and for 30 days after - Must not donate sperm for 30 days after the study
  • Must have suspected or confirmed NASH fibrosis shown by one of these: - Blood test showing PRO-C3 above 14 ng/mL or ELF score of 9 or higher - FibroScan showing liver stiffness of 8.5 kPa or higher - Liver biopsy within last 2 years showing appropriate fibrosis stage
  • Must have liver fat content of 8% or higher shown on special MRI scan during screening
  • For long-term extension phase: - Must provide new written consent - Must have completed all main study visits - Must have completed liver biopsy at Month 54

Who cannot join the trial?

16 criteria

  • Age below 18 years or above 75 years
  • Previous liver transplant or currently on a waiting list for liver transplant
  • History of cirrhosis (severe scarring of the liver) with complications
  • Current or recent history of significant alcohol consumption (more than 2 drinks per day for women or 3 drinks per day for men)
  • Presence of other types of liver disease, such as:
    • Viral hepatitis B or C
    • Autoimmune hepatitis (when the immune system attacks the liver)
    • Wilson's disease (inherited copper accumulation disorder)
    • History of heart failure or significant heart problems
    • Uncontrolled high blood pressure (above 160/95 mmHg)
    • Poorly controlled diabetes (blood sugar disorder) with HbA1c above 9.5%
    • Severe kidney disease requiring dialysis
    • Active cancer or cancer treatment within the past 5 years
    • Pregnancy or breastfeeding
    • Participation in another clinical trial within the past 30 days
    • Use of medications that could interfere with the study drug
    • History of bariatric surgery (weight loss surgery) within the past 5 years
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Investigated drugs

  • MGL-3196 (resmetirom)

    is a medication being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH), a serious liver condition. It is taken as an oral medication once daily. This drug is designed to help resolve NASH symptoms and prevent the progression of liver damage. It works by targeting liver cells and may help reduce liver fat, inflammation, and scarring (fibrosis).

  • Placebo

    is used as a control substance in this study to compare with the active medication. It looks identical to the real medication but contains no active ingredients.

What is already known about the treatment

Resmetirom (MGL-3196) - An oral medication administered once daily that belongs to the class of thyroid hormone receptor beta agonists, specifically designed for treating Non-Alcoholic Steatohepatitis (NASH) with fibrosis. The drug works by selectively activating thyroid hormone receptor beta in the liver, helping to reduce liver fat accumulation and inflammation without affecting other body tissues. Currently undergoing Phase 3 clinical trials, this medication is being evaluated for its ability to resolve NASH and prevent progression to cirrhosis, with promising results in improving liver fibrosis scores and reducing disease activity without worsening of fibrosis.

Investigated diseases

Non-Alcoholic Steatohepatitis (NASH) - A progressive liver condition characterized by fat accumulation in the liver, accompanied by inflammation and cell damage. NASH occurs when excess fat builds up in liver cells, leading to swelling and damage over time. The condition develops in people who drink little to no alcohol but have other risk factors such as obesity or diabetes. The disease can cause scarring of liver tissue (fibrosis) and lead to changes in liver structure. NASH is part of a group of conditions called non-alcoholic fatty liver disease (NAFLD).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510626-89-00Protocol codeMGL-3196-11Estimated enrolment1 759 patientsSponsorMadrigal Pharmaceuticals Inc.

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