The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease

Multi‐center, double‐blind, randomized, placebo‐controlled, parallel group Phase IV study with two treatment arms: evolocumab SC 420 mg/dL QM or matching placebo. The population will include 40 participants with documented Atherosclerotic Vascular Disease (CAD, Stroke, PAD) and type 2 diabetes who receive treatment with maximal tolerated statin therapy and stable doses of anti‐hyperglycemic therapy. Subjects will be followed for 12 weeks during the treatment phase, maintaining the double‐blind throughout. Assessments of ACUTE and SHORT‐TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of endothelial function will be measured at baseline, Week 2, and Week 12. Safety assessments will be undertaken at each study visit.