NCT05923281

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Statin Intolerant Hypercholesterolemia-

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kowa Company, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant\* Hypercholesterolemia,using placebo as a controll. \*Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	K-877 0.2 mg/day (once daily)	K-877 0.2mg tablet
DRUG	K-877 0.4 mg/day (once daily)	K-877 0.2mg tablet
DRUG	Placebo (once daily)	Placebo tablet

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-08-07
• Completion: 2024-08-07
• First posted: 2023-06-28
• Last updated: 2025-12-11

Locations

22 sites across 1 country: Japan