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

Author:

Wang Xiaozeng1ORCID,Qiu Miaohan1,Cheng Zhifeng2,Ji Xianyou3,Chen Jiyan4ORCID,Zhu Hong5,Tang Yida6,Huang Zhouqing7ORCID,Su Guohai8,Wang Gaopin9,Huang Zhijun10ORCID,Yao Zhuhua11,Lin Jinxiu12,Sun Yihong13ORCID,Li Shunhui14,Shao Cong15,Zhao Yi15ORCID,Bai Xuelian15ORCID,Han Yaling1ORCID

Affiliation:

1. General Hospital of Northern Theater Command Shenyang China

2. The Fourth Hospital of Harbin Medical University Harbin China

3. Daqing People’s Hospital Daqing China

4. Guangdong General Hospital Guangzhou China

5. The Affiliated Hospital of Xuzhou Medical University Xuzhou China

6. Peking University Third Hospital Beijing China

7. The First Affiliated Hospital of Wenzhou Medical University Wenzhou China

8. Jinan Central Hospital Jinan China

9. The First Affiliated Hospital of Jinzhou Medical University Jinzhou China

10. The Third Xiangya Hospital of Central South University Changsha China

11. Tianjin People’s Hospital Tianjin China

12. The First Affiliated Hospital of Fujian Medical University Fuzhou China

13. China‐Japan Friendship Hospital Beijing China

14. The First Hospital of Nanchang Nanchang China

15. Shanghai Junshi Biosciences Co., Ltd. Shanghai China

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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