NCT04447820

Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	K-877-ER (Dose A)	Dose A Oral Administration
DRUG	K-877-ER (Dose B)	Dose B Oral Administration
DRUG	K-877-IR	K-877-IR Oral Administration

Timeline

• Start date: 2020-06-10
• Primary completion: 2020-12-03
• Completion: 2020-12-03
• First posted: 2020-06-25
• Last updated: 2023-12-22
• Results posted: 2023-12-22

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study