%0 Journal Article
%T Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.
%A Wang X
%A Qiu M
%A Cheng Z
%A Ji X
%A Chen J
%A Zhu H
%A Tang Y
%A Huang Z
%A Su G
%A Wang G
%A Huang Z
%A Yao Z
%A Lin J
%A Sun Y
%A Li S
%A Shao C
%A Zhao Y
%A Bai X
%A Han Y
%J J Am Heart Assoc
%V 13
%N 11
%D 2024 Jun 4
%M 38818934
%F 6.106
%R 10.1161/JAHA.123.033669
%X <B>BACKGROUND: </B>A phase 3 trial was conducted to evaluate the efficacy and safety of ongericimab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, as an add-on treatment to optimized lipid-lowering therapy in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia.<BR><B>RESULTS: </B>A total of 806 patients who were receiving stable and optimized lipid-lowering therapy but did not achieve their low-density lipoprotein cholesterol (LDL-C) targets were enrolled and randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150 mg or matching placebo every 2 weeks, or ongericimab 300 mg or matching placebo every 4 weeks for 52 weeks. Efficacy and safety were evaluated in 802 patients who received at least 1 dose of ongericimab or placebo. The primary end point was the percentage change in LDL-C from baseline to week 24. Our findings demonstrated that the least-squares mean difference of percentage change in LDL-C from baseline to week 24 was -67.7% (95% CI, -72.5% to -63.0%; P<0.0001) in the ongericimab 150 mg every 2 weeks group compared with the placebo every 2 weeks group, and -61.2% (95% CI, -67.1% to -55.2%; P<0.0001) in the ongericimab 300 mg every 4 weeks group compared with the placebo every 4 weeks group. These reductions were sustained up to week 52. Furthermore, treatment with ongericimab favorably altered other lipid parameters. A similar incidence of adverse events was observed in the ongericimab and placebo groups.<BR><B>CONCLUSIONS: </B>Ongericimab, as an add-on treatment to optimized lipid-lowering therapy, significantly reduced LDL-C and was well-tolerated in Chinese patients with primary hyperlipidemia and mixed dyslipidemia who did not achieve their LDL-C targets.<BR><B>BACKGROUND: </B>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04781114.