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Madrigal Pharmaceuticals Initiates the MAESTRO-NASH Outcomes Study Evaluating Resmetirom for the Treatment of Patients with Compensated NASH Cirrhosis

Published: 2022-08-31 12:00:00 ET

CONSHOHOCKEN, Pa., Aug. 31, 2022 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced initiation of the “MAESTRO-NASH Outcomes” study of resmetirom (recruiting, first patient screened). MAESTRO-NASH Outcomes is a Phase 3, double-blind, randomized, placebo-controlled study that will noninvasively measure progression to liver decompensation events in approximately 700 patients with compensated NASH cirrhosis. It is the fourth Phase 3 MAESTRO study of resmetirom, joining the MAESTRO-NAFLD-1 safety study, which reported positive data in January 2022, the ongoing MAESTRO-NAFLD Open-Label Extension study, and the pivotal MAESTRO-NASH biopsy study, which is on track for a topline data readout in Q4 2022.

The primary endpoint of MAESTRO-NASH Outcomes is the incidence of composite liver-related outcome events, including all-cause mortality, liver transplant, hepatic decompensation (ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage), and confirmed increase of Model for End-Stage Liver Disease (MELD) score from

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