Positive Results from Evolocumab Phase 3 Trial
Amgen announced positive top-line results from its Phase 3 LAPLACE-2 trial of evolocumab (AMG 145) in combination with statin therapy for the treatment of high cholesterol. Evolocumab is a fully human monoclonal antibody that that is designed to bind to proprotein convertase subtilisin/kexin type 9 (PCSK9) proteins that target LDL receptors and inhibit PCSK9 from adhering to LDL receptors on the surface of the liver.
The LAPLACE-2 (LDL-C Assessment with P CSK9 Monoclonal Antibody Inhibition Combined with Statin Therapy-2) trial is a randomized, multicenter, double-blind, placebo-, and ezetimibe-controlled study that included 1,896 patients with primary hypercholesterolemia and mixed dyslipidemia to evaluate the safety, tolerability, and efficacy of evolocumab in combination with statin therapy. Patients were randomized to one of 24 treatment groups in a two-step randomization.
The co-primary endpoints were both met, with the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.
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