US-based biopharmaceutical company Madrigal Pharmaceuticals has finished enrolling patients in a trial of Rezdiffra (resmetirom), a drug candidate for compensated non-alcoholic steatohepatitis (NASH) cirrhosis.
MAESTRO-NASH OUTCOMES is a double-blind, randomised, placebo-controlled Phase III study involving 845 patients with compensated NASH cirrhosis and three metabolic risk factors.
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Subjects in the trial are being randomised into a 3:1 ratio to receive either 80mg of resmetirom or a matching placebo orally once daily.
The trial’s primary endpoint is the incidence of composite outcome events related to liver function.
Its duration is anticipated to be between two to three years, which is the time expected to gather the necessary number of clinical outcome events.
Resmetirom is a liver-directed thyroid hormone receptor beta (THR-β) agonist that targets the fundamental causes of NASH, a severe stage of non-alcoholic fatty liver disease (NAFLD).
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By GlobalDataMadrigal Pharmaceuticals CEO Bill Sibold said: “The MAESTRO-NASH OUTCOMES trial is important for patients and the NASH field more broadly because there is an urgent unmet need for therapies that can prevent progression to the devastating complications of decompensated cirrhosis and by extension reduce the need for liver transplants due to NASH.
“Today’s enrolment milestone brings us one step closer to our goal of delivering the first effective therapy to patients who currently have no approved treatment options for compensated NASH cirrhosis.”
The MAESTRO-NASH OUTCOMES trial is one of several Phase III clinical studies that Madrigal is carrying out to evaluate resmetirom.
Other trials of the drug include MAESTRO-NASH, which focuses on moderate to advanced fibrosis, and the MAESTRO-NAFLD-1 study.
A positive result from this study could support the full approval of Rezdiffra for treating noncirrhotic NASH, which is also referred to as metabolic dysfunction-associated steatohepatitis.
Earlier this year, the US Food and Drug Administration granted accelerated approval for Rezdiffra to treat noncirrhotic NASH.
