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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 on Resmetirom effects in NASH cirrhosis patients.

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18 years and older
All
Phase 3

This study looks at how a drug called resmetirom affects people with a liver disease known as non-alcoholic steatohepatitis (NASH) cirrhosis. NASH cirrhosis is a condition where the liver is damaged due to fat buildup. The study is double-blind, meaning neither the doctors nor the participants know who gets the actual drug or a placebo (a fake pill with no medicine). Participants will take an 80 mg pill of resmetirom or placebo every morning for about 3 years. The main goal is to see how long it takes for patients to have a liver-related event, like needing a liver transplant or experiencing certain liver problems. Before starting, there's a screening period of up to 60 days. The study is for people with well-compensated NASH cirrhosis, meaning their liver is still working well. However, people with other liver diseases or severe liver damage aren't eligible.

  • Study duration is approximately 3 years with up to 60 days for screening.
  • Participants take a pill every morning and won't know if it's the real drug or placebo.
  • Key focus is on liver-related health events during the study period.
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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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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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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