Benzinga | Jul 13, 2021 05:49PM EDT

Madrigal Pharmaceuticals Offers Patients Resmetirom In Planned Open Label Active Treatment Extension Of Phase 3 MAESTRO-NAFLD-1 Clinical Study

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219). MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH. The study is due to complete later this year with measures of safety and efficacy including reduction in imaging and biomarker measures of NASH, as well as the lowering of LDL-cholesterol and other atherogenic lipids.



MAESTRO-NAFLD-OLE allows patients who complete MAESTRO-NAFLD-1 to consent to 52 weeks of active treatment with resmetirom, making this treatment available to patients who were assigned to placebo in the main study and allowing patients who were on resmetirom to continue treatment with the drug.

"Patients and physicians participating in MAESTRO-NAFLD-1 are enthusiastic about the opportunity to continue active treatment with resmetirom in the extension study," stated Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal. "We have achieved positive results with resmetirom in our Phase 2 clinical trial, and the recently reported results from the ongoing open-label arm of Phase 3 MAESTRO-NAFLD-1. NASH is a chronic disease that will require long-term dosing and the extension study will generate additional valuable safety and efficacy data."