Outcomes
NAFLD fibrosis, inflammation, TEAEs, fibrosis
ADVERSE EVENT, ADVERSE EVENTS, INFLAMMATION, FIBROSIS, SECONDARY
The primary endpoint was plasma AOC3 activity relative to baseline measured as a percentage, 24 hours post dose after 12 weeks of treatment. AOC3 activity was measured via a quasi-quantitative, one-step fluorometric activity assay (Amplex® Red Monoamine Oxidase Assay Kit). In this assay, hydrogen peroxide, produced during oxidation of benzylamine by AOC3, was used as a proxy for quantification of AOC3 activity. Hydrogen peroxide oxidised Amplex Red to its fluorescent analogue, resorufin, allowing for colorimetric analysis of AOC3 activity. The number and percentage of patients with drug-related adverse events (AEs) was a secondary endpoint in this trial. Safety and tolerability were further assessed based on the general occurrence of TEAEs, safety laboratory parameters, physical examination, vital sign measurements and a 12-lead electrocardiogram. The intensity of AEs was classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Secondary biomarker endpoints were relative changes from baseline in ALT, AST, AP, GGT, CK-18 caspase, and CK-18 total at Week 12. Further biomarker endpoints included markers of metabolism (e.g. fasting plasma glucose, insulin and lipids), inflammation (e.g. interleukins 1β, 6 and 8, and interferon γ) and markers and scores reflecting fibrosis status (e.g. APRI, Fib-4 score, ELF score, NAFLD fibrosis score and Pro-C3).