Data from the phase III MAESTRO-NAFLD-1 study of resmetirom in NAFLD presented at International Liver Congress (EASL 2022).- Madrigal Pharmaceuticals
Madrigal Pharmaceuticals announced data from multiple resmetirom abstracts presented at the European Association for the Study of the Liver’s International Liver Congress (EASL 2022), including a late-breaking presentation of data from the Phase III MAESTRO-NAFLD-1 study and three additional oral presentations from the resmetirom clinical development program.
Primary and key secondary endpoints from the double-blind, placebo-controlled, 969-patient MAESTRO-NAFLD-1 safety study were achieved; resmetirom was safe and well tolerated and provided significant reductions in liver fat (measured using magnetic resonance imaging proton density fraction (MRI-PDFF) and FibroScan controlled attenuation parameter (CAP)), LDL-C, and other atherogenic lipids vs placebo.
Patients treated with resmetirom also achieved significant reductions relative to placebo in ALT, AST, and GGT. For those patients with sufficient baseline liver stiffness, as measured by FibroScan vibration-controlled transient elastography (VCTE) or magnetic resonance elastography (MRE), responder analyses showed statistically significant VCTE and MRE responses in the resmetirom groups compared to placebo. Adverse event-related withdrawals were uncommon in the MAESTRO-NAFLD-1 study. The most common adverse event reported with greater frequency in the resmetirom groups vs placebo was generally mild diarrhea or increased stool frequency at the beginning of therapy.
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