American Journal of Gastroenterology | August 2021
Authors: Stephen A. Harrison, Seth J. Baum, Nadege T. Gunn, Ziad H. Younes, Anita Kohli, Rashmee Patil, Margaret J. Koziel, Harinder Chera, Jeff Zhao, Manu Chakravarthy
AXA1125 and AXA1957 are novel, orally administered endogenous metabolic modulator compositions, specifically designed to simultaneously support multiple metabolic and fibroinflammatory pathways associated with nonalcoholic fatty liver disease (NAFLD). This study assessed safety, tolerability, and biologic activity of AXA1125 and AXA1957 in NAFLD.
AXA1125 and AXA1957 in NAFLD.
Methods: In this multicenter, 16-week, placebo-controlled, single-blind, randomized clinical study in NAFLD subjects stratified by type 2 diabetes (T2D), AXA1125 24 g, AXA1957 13.5 g or 20.3 g, or placebo were administered twice daily. Key metabolism (magnetic resonance imaging-proton density fat fraction [MRI-PDFF], homeostasis model assessment of insulin resistance [HOMA-IR]), and fibroinflammation markers (alanine aminotransferase [ALT], corrected T1 [cT1], cytokeratin-18 [CK-18] M65, N- terminal type III collagen propeptide [Pro-C3]) were evaluated. Safety outcomes included adverse events and standard laboratory assessments.