Stephen A Harrison, Manal F Abdelmalek, Guy Neff, Nadege Gunn, Cynthia D Guy, Naim Alkhouri, Mustafa R Bashir, Bradley Freilich, Anita Kohli, Arun Khazanchi, Muhammad Y Sheikh, Mark Leibowitz, Mary E Rinella, Mohammad S Siddiqui, Mark Kipnes, Sam E Moussa, Ziad H Younes, Meena Bansal, Seth J Baum, Brian Borg, Peter J Ruane, Paul J Thuluvath, Mildred Gottwald, Mujib Khan, Charles Chen, Liza Melchor-Khan, William Chang, Alex M DePaoli, Lei Ling, Hsiao D Lieu
BACKGROUND: Non-alcoholic steatohepatitis (NASH) is characterised by hepatic steatosis, inflammation, and injury, and is associated with an increased risk of liver transplantation and death. NASH affects more than 16 million people in the USA, and there is no approved therapy. The aim of this study was to evaluate the safety and efficacy of aldafermin, an engineered analogue of the gut hormone fibroblast growth factor 19 (FGF19). METHODS: In this randomised, double-blind, placebo-controlled, phase 2b study (ALPINE 2/3) in patients with biopsy-confirmed NASH and stage 2 or 3 fibrosis, we randomly assigned patients stratified by fibrosis stage in a 1:1:1:1 ratio to receive placebo, aldafermin 0·3 mg, 1·0 mg, or 3·0 mg once daily for 24 weeks at 30 study sites in the USA...
July 2022: Lancet. Gastroenterology & Hepatology