Michael J Koren, Olivier Descamps, Yoshiki Hata, Ellen Margo Hengeveld, G Kees Hovingh, Ignatios Ikonomidis, Maria D Radu Juul Jensen, Irene Hedelund Langbakke, Fabrice M A C Martens, Anette Luther Søndergaard, Adam Witkowski, Wolfgang Koenig
BACKGROUND: Currently available injectable drugs that target proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce serum LDL cholesterol and improve cardiovascular outcomes. This phase 2 study assessed NNC0385-0434, an oral PCSK9 inhibitor, in individuals receiving oral lipid-lowering therapy. METHODS: In this randomised, double-blind, placebo-controlled and active-controlled trial, 42 research sites across seven countries (Belgium, Germany, Greece, Japan, the Netherlands, Poland, and the USA) recruited individuals with established atherosclerotic cardiovascular disease (aged ≥40 years) or at high risk of atherosclerotic cardiovascular disease (aged >50 years), who had LDL cholesterol concentration of at least 1·8 mmol/L and were receiving maximum tolerated statins and stable lipid-lowering therapy...
March 2024: Lancet Diabetes & Endocrinology