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A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

Join a study to assess Resmetirom effects in NASH cirrhosis patients.

Recruiting
18 years and older
All
Phase 3

This study is exploring a medicine called resmetirom for people with a liver condition called well-compensated NASH cirrhosis. NASH stands for Non-Alcoholic Steatohepatitis, which is a liver disease that happens without alcohol use and can lead to cirrhosis (liver scarring). The study is double-blind, meaning neither the researchers nor the participants know who is getting the real medicine or a placebo (a fake pill). Participants take an 80 mg pill of resmetirom or placebo once each morning.

Researchers will watch for certain health events, such as liver or heart problems, to see how well the medicine works. This study will last about three years, with some checks every now and then. Participants are chosen randomly, like flipping a coin, to be in one of the two groups.

  • The study includes a screening period of up to 60 days and a treatment period of about 3 years.
  • You must have well-compensated NASH cirrhosis and meet specific health criteria to join.
  • Participants must not have other chronic liver diseases or a history of liver problems.
Study details
    NASH
    Cirrhosis
    Liver

NCT05500222

Madrigal Pharmaceuticals, Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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