A Study of IBI306 in Participants With Hypercholesterolemia

Phase 3 Completed 306 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.

Timeline

Start: 2021-02-09
Primary completion: 2021-11-09
Completion: 2022-01-28

Outcome

Met primary endpoint

paper and -5.8% (1.8%) in the placebo group (difference: -63.0%; [95% CI: -66.5% to -59.6%]; P < 0.0001). PMID 37614541 ↗

release “The results of the CREDIT-4 study demonstrated that tafolecimab Q4W treatment significantly reduced LDL-C levels and improved other lipid parameters such as lipoprotein(a).” innoventbio.com ↗

Publications

Qi L, Liu D, Qu Y, Chen B, Meng H, Zhu L, Li L, Wang S, Liu C, Zheng G, Lian Q, Yin G, Lv L, Lu D, Chen X, Xue F, An P, Li H, Deng H, Li L, Qian L, Huo Y. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tafolecimab	Monoclonal antibody	450 mg	Subcutaneous