Press release
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Madrigal Pharmaceuticals Positive Resmetirom Data from Completed Open - Label Portion of Phase 3 MAESTRO - NAFLD - 1 Clinical Study Presented at American Association for the Study of Liver Diseases ( AASLD ) The Liver Meeting® Digital Experience 2021 November 12 , 2021 • This final read - out of the 52 - week open - label resmetirom 100 mg treatment study of 171 patients with presumed non - alcoholic steatohepatitis ( NASH ) and fibrosis , identified using non - invasive tests , demonstrate that resmetirom : o provided rapid and sustained reduction in liver fat and liver volume ; o provided rapid and sustained reductions in liver fibrosis , as measured by biomarkers , magnetic resonance elastography ( MRE ) and FibroScan ; o reduced atherogenic lipids , including LDLC and triglycerides , liver enzymes and inflammatory biomarkers ; 。 was safe and well - tolerated at 100 mg per day in patients treated for 52 weeks . • This “ real - life " study supports the potential use of non - invasive assessments to diagnose and manage NASH with fibrosis , including assessment of individual patient response to resmetirom treatment . CONSHOHOCKEN , Pa . , Nov. 12 , 2021 ( GLOBE NEWSWIRE ) -- Madrigal Pharmaceuticals , Inc. ( NASDAQ : MDGL ) , today announced the presentation of positive clinical data from the open - label portion of its ongoing MAESTRO - NAFLD - 1 ( non - alcoholic fatty liver disease ) study of resmetirom at the AASLD The Liver MeetingⓇ , being held virtually November 12th - 15th , 2021. Madrigal will host a webcast and conference call after the meeting on Tuesday , November 16th at 8:00 AM EST to summarize and discuss the data . " These new data from MAESTRO - NAFLD - 1 , our ongoing Phase 3 non - invasive study of resmetirom in patients with presumed NASH , reinforce and deepen our understanding of the therapeutic potential of resmetirom . The positive safety and efficacy findings from the open - label portion of MAESTRO - NAFLD - 1 are particularly encouraging as we prepare to report initial topline data from the placebo - controlled double - blind portion of the study by year - end , " stated Paul Friedman , M.D. , Chief Executive Officer of Madrigal . Becky Taub , M.D. , Chief Medical Officer and President of Research & Development of Madrigal added , " The completed 52 - week open - label MAESTRO - NAFLD - 1 results being presented at The Liver Meeting 2021 demonstrate resmetirom's ability to potently reduce hepatic fat and liver volume in all subgroups of patients with NASH , including patients stably treated with diabetes medications such as GLP - 1 agonists and SGLT2 inhibitors . Liver volume reduction may be explained in part by reduction in liver fat , but is also likely driven by other factors related to resmetirom's mechanism of action , potentially including effects on inflammation . Consistent with previous studies , there was a low discontinuation rate from adverse effects with no changes in central thyroid hormone axis or