Madrigal Pharmaceuticals is a biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone pathway in the liver to address a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Resmetirom, Madrigal’s lead compound, is currently being evaluated in two Phase 3 studies: MAESTRO-NASH (NCT03900429) and MAESTRO-NAFLD-1 (NCT04197479).
Resmetirom is a selective thyroid hormone receptor beta agonist for the treatment of patients with NASH and significant liver fibrosis. MAESTRO-NASH, a 52-week, pivotal serial liver biopsy study in approximately 900 patients with NASH and fibrosis stage 2/3 fibrosis, and MAESTRO-NAFLD-1 a 52-week, 1200-patient real life NASH study in which the diagnosis is made non-invasively using imaging and biomarker assessments. The endpoints in MAESTRO-NASH include resolution of NASH, a 1-point reduction in liver fibrosis on serial liver biopsy, and reduction of LDL cholesterol, and MAESTRO-NAFLD-1 endpoints include safety, lipids, MRI-PDFF and fibrosis biomarkers. Together, MAESTRO-NASH and MAESTRO-NAFLD-1 provide a comprehensive data set to establish the efficacy and safety of resmetirom, consistent with regulatory requirements to support its potential for accelerated approval for the treatment of patients with NASH with significant liver fibrosis.
Dr. Pete D. Vu, Medical Science Liaison
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