A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis

• Published in: The New England journal of medicine Vol. 390; no. 6; pp. 497 - 509
• Main Authors: Harrison, Stephen A., Bedossa, Pierre, Guy, Cynthia D., Schattenberg, Jörn M., Loomba, Rohit, Taub, Rebecca, Labriola, Dominic, Moussa, Sam E., Neff, Guy W., Rinella, Mary E., Anstee, Quentin M., Abdelmalek, Manal F., Younossi, Zobair, Baum, Seth J., Francque, Sven, Charlton, Michael R., Newsome, Philip N., Lanthier, Nicolas, Schiefke, Ingolf, Mangia, Alessandra, Pericàs, Juan M., Patil, Rashmee, Sanyal, Arun J., Noureddin, Mazen, Bansal, Meena B., Alkhouri, Naim, Castera, Laurent, Rudraraju, Madhavi, Ratziu, Vlad
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 08.02.2024
• Subjects: Adult; Biopsy; Cholesterol; Cirrhosis; Clinical outcomes; Diabetes; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Endocrinology; Endocrinology General; Fatty liver; FDA approval; Fibrosis; Gastroenterology; Gastroenterology General; Human health and pathology; Humans; Inflammation; Life Sciences; Liver - diagnostic imaging; Liver - drug effects; Liver - pathology; Liver cirrhosis; Liver Cirrhosis - drug therapy; Liver Cirrhosis - etiology; Liver Cirrhosis - pathology; Liver Disease; Liver diseases; Metabolism; Non-alcoholic Fatty Liver Disease - complications; Non-alcoholic Fatty Liver Disease - drug therapy; Non-alcoholic Fatty Liver Disease - pathology; Patients; Placebos; Pyridazines - therapeutic use; Research centers; Thyroid Hormone Receptors beta - agonists; Treatment Outcome; Uracil - analogs & derivatives
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa2309000

Resmetirom is a selective agonist of THR-β. In adults with nonalcoholic steatohepatitis and fibrosis, daily resmetirom (80 mg or 100 mg) was superior to placebo with respect to NASH resolution and fibrosis improvement.