A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

NCT04998981 ↗

Phase 3 Completed 353 enrolled Kowa Company, Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C

Timeline

Start: 2021-09-17
Primary completion: 2023-02-02
Completion: 2023-02-02

Outcome

Met primary endpoint

paper Pemafibrate 0.4 mg/d significantly reduced TG levels compared with that in both placebo (p＜0.0001) and fenofibrate groups (p=0.0083). PMID 39098034 ↗

Publications

Results Dai W, Lv Q, Li Q, Fu L, Zhang Y, Zhang Y, Liu L, Tanigawa R, Kunitomi K, Kamei R, Suganami H, Ma C. Efficacy and Safety of Pemafibrate, a Novel Selective PPARalpha Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial. J Atheroscler Thromb. 2025 Feb 1;32(2):125-140. doi: 10.5551/jat.64112. Epub 2024 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fenofibrate	Small molecule	200 mg	—
Subject	K-877	Unknown	0.1 mg	—
Subject	K-877	Unknown	0.2 mg	—