SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

Summary

This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.

Timeline

Start

2021-04-14

Primary completion

2022-08-12

Completion

2022-08-12

Outcome

Met primary endpoint

paper with a treatment difference of -49.8% (95% CI, -55.8 to -43.9%; P < 0.0001). PMID 40911402 ↗

Publications

• Li L, Zhou Y, Deng C, Sheng J, Peng D, Ling Z, Wang L, Dai C, Huang K, Lian Q, Yu Z, Yang H, Hu Y, Dong Y, Wang N, Wang Z, Zhang W, Han X, Yao Z, Liu Q, Liang Y, Xu B, Wang Y, Zhong T, Chen J. Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study. Cardiovasc Res. 2025 Oct 24;121(12):1856-1864. doi: 10.1093/cvr/cvaf155.
• Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

Drugs

Indications