CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has announced two-year results from the open-label arm of its Phase 3 MAESTRO-NAFLD-1 trial, showcasing the potential of Rezdiffra for treating patients with compensated MASH cirrhosis (F4c). The trial revealed statistically significant reductions in liver stiffness, improvements in fibrosis biomarkers, and better risk profiles for clinically significant portal hypertension (CSPH).
A notable finding showed that 65% of patients with CSPH at baseline moved into lower risk categories after two years of treatment. On average, patients achieved a 6.7 kPa reduction in liver stiffness, considered a significant milestone linked to a decreased progression toward end-stage liver disease. Dr. Naim Alkhouri, Chief Academic Officer at Summit Clinical Research, emphasized, “Rezdiffra demonstrated broad, sustained efficacy across multiple noninvasive parameters at two years of treatment… the totality of data in this high-risk population…is highly encouraging.”
The trial, which enrolled 122 patients, showed a safety profile consistent with previous studies. Rezdiffra was well-tolerated, with a low rate of discontinuation, and the most common adverse events included diarrhea, COVID-19, and nausea. Two deaths occurred during the study but were unrelated to Rezdiffra.
CSPH, a severe consequence of cirrhosis, carries risks such as variceal bleeding and hepatic encephalopathy. The findings also highlighted Rezdiffra’s ability to help 35% of patients achieve liver stiffness measurements consistent with F3 fibrosis, indicating potential cirrhosis reversal.
David Soergel, M.D., Chief Medical Officer of Madrigal, commented, “These two-year open-label data from MAESTRO-NAFLD-1 add important clinical evidence that supports our confidence in the ongoing, fully enrolled Phase 3 outcomes trial of Rezdiffra in compensated MASH cirrhosis.”
At 8 a.m. EDT on May 13, 2025, Madrigal will host a webcast to review two-year data from the compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial. To join, visit the investor relations section of the Madrigal website or click here to register.
Bolstered by these results, Madrigal remains focused on the continued development of Rezdiffra as a promising treatment for patients at risk of progressing to severe liver complications.
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