CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has successfully completed enrollment for its MAESTRO-NASH OUTCOMES trial, a critical study evaluating the efficacy of resmetirom in patients with compensated NASH cirrhosis. This milestone marks a significant step towards addressing a pressing need in the field of liver disease, where currently no approved treatments exist for this advanced stage of nonalcoholic steatohepatitis (NASH).
The trial, a Phase 3 double-blind study, involves 845 participants and aims to measure the progression of liver decompensation events. With a primary focus on patients with well-compensated NASH cirrhosis, the study assesses the impact of resmetirom—an oral, liver-targeted THR-β agonist—on slowing or preventing disease progression. The study’s primary endpoint is the incidence of composite liver-related outcomes.
Bill Sibold, CEO of Madrigal, emphasizes the urgency of developing therapies for NASH, citing the high incidence of liver transplants due to the disease, particularly among women in the U.S. “The MAESTRO-NASH OUTCOMES trial is crucial not only for patients but also for advancing the treatment landscape of NASH,” he stated.
The drug resmetirom has previously shown promise in its antifibrotic capabilities, as demonstrated in earlier studies, including the MAESTRO-NAFLD-1 study. Dr. Becky Taub, Madrigal’s Chief Medical Officer, underscores the potential of resmetirom to set a new standard in NASH treatment, highlighting the positive outcomes in previous trials that have bolstered confidence in its efficacy.
NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), poses a growing challenge as it increases the risk of liver-related mortality and necessitates liver transplants. The disease is often associated with metabolic risk factors such as obesity and type 2 diabetes, further complicating patient outcomes.
Madrigal’s comprehensive Phase 3 program for resmetirom not only seeks to provide a viable treatment option for NASH but also aims to redefine the therapeutic approach to this complex condition. The company’s ongoing research and commitment to NASH signal a potential turning point in managing a disease that affects millions globally.
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