Abstract
Global guidelines for the management of high-cardiovascular-risk patients include aggressive goals for low-density lipoprotein cholesterol (LDL-C). Statin therapy alone is often insufficient to reach goals and nonstatin options have limitations. Here, we tested the lipid-lowering effects of the cholesteryl ester transfer protein (CETP) inhibitor drug obicetrapib in a randomized, double-blind, placebo-controlled trial in dyslipidaemic patients (n = 120, median LDL-C 88 mg dl−1) with background high-intensity statin treatment (NCT04753606). Over the course of 8 weeks, treatment with 5 mg or 10 mg obicetrapib resulted in a significant decrease as compared with placebo in median LDL-C concentration (by up to 51%; P < 0.0001), the primary trial outcome. As compared with placebo, obicetrapib treatment also significantly (P < 0.0001) decreased apolipoprotein B (by up to 30%) and non-high-density lipoprotein cholesterol (non-HDL-C) concentration (by up to 44%), and significantly (P < 0.0001) increased HDL-C concentration (by up to 165%; the secondary trial outcomes) and had an acceptable safety profile. These results support the potential of obicetrapib to address an unmet medical need for high-cardiovascular-risk patients.
【초록키워드】 Treatment, therapy, Trial, outcome, outcomes, Randomized, Protein, management, placebo-controlled trial, Patient, statin, Placebo, LDL-C, inhibitor, patients, safety profile, Concentration, double-blind, medical need, Support, Low-Density Lipoprotein cholesterol, HDL-C, transfer, lipoprotein cholesterol, significant decrease, CETP, cholesteryl ester, over, Effect, limitations, Course, tested, significantly, include, median, 【제목키워드】 Randomized, phase 2 trial, Combination, Lipid, Effect, CETP inhibitor,