NCT04998981

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

A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Kowa Company, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	K-877 0.1 mg tablet	K-877 0.1 mg tablet x 2 twice daily
DRUG	Fenofibrate 200 mg capsule	Fenofibrate 200 mg capsule once daily
DRUG	Placebo tablet	Placebo tablet x 2 twice daily
DRUG	Placebo capsule	Placebo capsule once daily
DRUG	K-877 0.1 mg tablet	K-877 0.1 mg tablet twice daily
DRUG	Placebo tablet	Placebo tablet twice daily

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2021-08-10
• Last updated: 2025-05-23

Locations

33 sites across 1 country: China