A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Phase 3 Active not recruiting 810 enrolled Madrigal Pharmaceuticals, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

Timeline

Start: 2021-07-09
Primary completion: 2027-03
Completion: 2027-04

Publications

Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Resmetirom	Small molecule	40 mg	Oral
Subject	Resmetirom	Small molecule	80 mg	Oral
Subject	Resmetirom	Small molecule	100 mg	Oral

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Summary

Timeline

Publications

Drugs

Indications