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Clinical Trial
. 2024 Jun 4;13(11):e033669.
doi: 10.1161/JAHA.123.033669. Epub 2024 May 31.

Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia

Xiaozeng Wang  1 , Miaohan Qiu  1 , Zhifeng Cheng  2 , Xianyou Ji  3 , Jiyan Chen  4 , Hong Zhu  5 , Yida Tang  6 , Zhouqing Huang  7 , Guohai Su  8 , Gaopin Wang  9 , Zhijun Huang  10 , Zhuhua Yao  11 , Jinxiu Lin  12 , Yihong Sun  13 , Shunhui Li  14 , Cong Shao  15 , Yi Zhao  15 , Xuelian Bai  15 , Yaling Han  1
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Free article
Clinical Trial

Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia

Xiaozeng Wang et al. J Am Heart Assoc. .
Free article

Abstract

Background: 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.

Methods and results: 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.

Conclusions: 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.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04781114.

Keywords: PCSK9; hypercholesterolemia; lipid‐lowering therapy; low‐density lipoprotein cholesterol; mixed dyslipidemia.

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