A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Summary

A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.

Timeline

Start

2019-09-13

Primary completion

2019-12-24

Completion

2019-12-24

Outcome

Met primary endpoint

paper indicating that XR 0.4 and XR 0.8 mg/day were not inferior to IR 0.2 mg/day. PMID 39322570 ↗

Publications

• Results Yamashita S, Araki E, Arai H, Yokote K, Tanigawa R, Saito A, Suganami H, Minamikawa S, Ishibashi S. Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study. J Atheroscler Thromb. 2025 Mar 1;32(3):367-384. doi: 10.5551/jat.65001. Epub 2024 Sep 26.

Drugs

Indications