drugset / Trial / NCT04716595
A Phase III Long Term Study of K-877 Extended Release Tablet
RandomizedParallel-groupOpen-labelTreatment
Summary
To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-06-13
- Completion
- 2022-06-13
Publications
- Results Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Furukawa D, Suganami H, Ishibashi S. Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. J Atheroscler Thromb. 2025 Aug 1;32(8):1006-1026. doi: 10.5551/jat.65350. Epub 2025 Feb 7.
- Tanigawa R, Ueno Y, Takahashi H, Saito A, Suganami H, Tanaka A. Pemafibrate Improves Cholestatic Markers Regardless of the Presence of Primary Biliary Cholangitis. Hepatol Res. 2026 Jul 15. doi: 10.1111/hepr.70244. Online ahead of print.