The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

Timeline

Start

2020-12-23

Primary completion

2022-05-25

Completion

2023-01-16

Publications

• Wang X, Qiu M, Cheng Z, Ji X, Chen J, Zhu H, Tang Y, Huang Z, Su G, Wang G, Huang Z, Yao Z, Lin J, Sun Y, Li S, Shao C, Zhao Y, Bai X, Han Y. Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia. J Am Heart Assoc. 2024 Jun 4;13(11):e033669. doi: 10.1161/JAHA.123.033669. Epub 2024 May 31.

Drugs

Indications