NCT03011450

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and \<2000 mg/dL and Mild or Moderate Renal Impairment.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	K-877
DRUG	Fenofibrate
DRUG	Placebo (for K-877)

Timeline

• Start date: 2016-11-26
• Primary completion: 2019-07-05
• Completion: 2019-07-05
• First posted: 2017-01-05
• Last updated: 2022-10-28
• Results posted: 2022-10-28

Locations

241 sites across 9 countries: United States, Belarus, Bulgaria, Czechia, Georgia, Hungary, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study