Stephen A Harrison, Pierre Bedossa, Cynthia D Guy, Jörn M Schattenberg, Rohit Loomba, Rebecca Taub, Dominic Labriola, Sam E Moussa, Guy W Neff, Mary E Rinella, Quentin M Anstee, Manal F Abdelmalek, Zobair Younossi, Seth J Baum, Sven Francque, Michael R Charlton, Philip N Newsome, Nicolas Lanthier, Ingolf Schiefke, Alessandra Mangia, Juan M Pericàs, Rashmee Patil, Arun J Sanyal, Mazen Noureddin, Meena B Bansal, Naim Alkhouri, Laurent Castera, Madhavi Rudraraju, Vlad Ratziu
BACKGROUND: Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. Resmetirom is an oral, liver-directed, thyroid hormone receptor beta-selective agonist in development for the treatment of NASH with liver fibrosis. METHODS: We are conducting an ongoing phase 3 trial involving adults with biopsy-confirmed NASH and a fibrosis stage of F1B, F2, or F3 (stages range from F0 [no fibrosis] to F4 [cirrhosis]). Patients were randomly assigned in a 1:1:1 ratio to receive once-daily resmetirom at a dose of 80 mg or 100 mg or placebo...
February 8, 2024: New England Journal of Medicine