Stephen A Harrison, Juan P Frias, Guy Neff, Gary A Abrams, K Jean Lucas, William Sanchez, Sudhanshu Gogia, Muhammed Y Sheikh, Cynthia Behling, Pierre Bedossa, Lan Shao, Doreen Chan, Erica Fong, Brittany de Temple, Reshma Shringarpure, Erik J Tillman, Timothy Rolph, Andrew Cheng, Kitty Yale
BACKGROUND: Fibroblast growth factor 21 (FGF21) regulates metabolism and protects cells against stress. Efruxifermin is a bivalent Fc-FGF21 analogue that replicates FGF21 agonism of fibroblast growth factor receptor 1c, 2c, or 3c. The aim of this phase 2b study was to assess its efficacy and safety in patients with non-alcoholic steatohepatitis (NASH) and moderate (F2) or severe (F3) fibrosis. METHODS: HARMONY is a multicentre, randomised, double-blind, placebo-controlled, 96-week, phase 2b trial that was initiated at 41 clinics in the USA...
December 2023: Lancet. Gastroenterology & Hepatology