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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447820
• Other study ID #: K-877-ER-201
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2020
• Est. completion date: December 3, 2020

Study information

• Verified date: November 2023
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to provide written informed consent before any study-specific evaluation is performed

• At screening, have a mean fasting TG level of =180 mg/dL and <550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of =200 mg/dL and <500 mg/dL

• Able to meet all inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

• Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study

• Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists

• Meet any other exclusion criteria outlined in clinical study protocol

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• K-877-ER (Dose A)
Dose A Oral Administration
• K-877-ER (Dose B)
Dose B Oral Administration
• K-877-IR
K-877-IR Oral Administration

Locations

Country	Name	City	State
United States	Pinnacle Research Group	Anniston	Alabama
United States	Medpace Clinical Pharmacology, LLC	Cincinnati	Ohio
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Columbus Regional Health	Columbus	Georgia
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Diabetes and Endocrinology Consultants, P.C.	Morehead City	North Carolina
United States	Summit Research Group, LLC	Munroe Falls	Ohio
United States	Progressive Medical Research	Port Orange	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Prism Research	Saint Paul	Minnesota
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Percentage Change in Fasting Triglyceride(s) (TG)		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in Remnant Cholesterol		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in Non-HDL-C		Baseline to Day 28
Secondary	Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)		Baseline to Day 28
Secondary	K-877 PK Parameters Cmax	Observed maximum measured plasma concentration (Cmax)	Day 28
Secondary	K-877 PK Parameters AUC (Tau)		Day 28