A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
Summary
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo. At least 100 patients will be enrolled in a 100 mg open-label arm and will include a special safety population (eg, patients with compensated NASH cirrhosis).
Timeline
- Start
- 2019-12-16
- Primary completion
- 2023-01-06
- Completion
- 2023-01-06
Outcome
Met primary endpoint
release “Primary and key secondary endpoints from the double-blind, placebo-controlled, 969-patient MAESTRO-NAFLD-1 safety study were achieved;” madrigalpharma.com ↗
release “The primary safety endpoint and several key secondary endpoints were met” madrigalpharma.com ↗
release “In January, Madrigal announced topline data from the Phase 3 MAESTRO-NAFLD-1 safety study of resmetirom. Primary and key secondary endpoints from the study were achieved” madrigalpharma.com ↗
release “The primary safety endpoint of MAESTRO-NAFLD-1 and key secondary endpoints were achieved:” madrigalpharma.com ↗
release “The primary safety endpoint of MAESTRO-NAFLD-1 and key secondary endpoints were achieved:” madrigalpharma.com ↗
Publications
- Younossi ZM, Nader F, Labriola D, Taub R, Racila A, Henry L, Stepanova M. Self-Reported Cognitive Function in Metabolic Dysfunction-associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis: A Post-hoc Analysis of the MAESTRO Resmetirom Trials. J Clin Exp Hepatol. 2026 Jul-Aug;16(4):103531. doi: 10.1016/j.jceh.2026.103531. Epub 2026 Mar 5.
- Alkhouri N, McRae MP, Taub R, Hill B, Imperial JC, Kittelson J, Moussa SE, Everson GT. The Cholate Challenge Test Quantified Baseline Functional Heterogeneity and Improvement in Response to Resmetirom in MASH-related Child-Pugh A Cirrhosis. Gastro Hep Adv. 2025 Aug 29;4(10):100785. doi: 10.1016/j.gastha.2025.100785. eCollection 2025.
- Harrison SA, Taub R, Neff GW, Lucas KJ, Labriola D, Moussa SE, Alkhouri N, Bashir MR. Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2023 Nov;29(11):2919-2928. doi: 10.1038/s41591-023-02603-1. Epub 2023 Oct 16.
- 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 | 80 mg | Oral |
| Subject | Resmetirom | Small molecule | 100 mg | Oral |