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

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: K-877-ER (Dose B); Drug: K-877-IR; Drug: K-877-ER (Dose A)

• Registration Number: NCT04447820
• Lead Sponsor: Kowa Research Institute, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Primary Completion: 2020-12-03
• Study Completion: 2020-12-03
• Disposition First Submitted: 2021-12-01
• Disposition First Submitted QC: 2021-12-01
• Disposition First Posted: 2021-12-07
• Status Verified: 2023-11
• Results First Submitted: 2023-11-30
• Results First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Results First Posted: 2023-12-22
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K-877-ER Dose B	K-877-ER (Dose B)	K-877-ER dose B administered once daily
K-877-IR	K-877-IR	K-877-IR administered twice daily.
K-877-ER Dose A	K-877-ER (Dose A)	K-877-ER dose A administered once daily

Primary Outcome Measures

Name	Time	Method
Estimated Percentage Change in Fasting Triglyceride(s) (TG)	Baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)	Baseline to Day 28
Percentage Change From Baseline to Day 28 in Remnant Cholesterol	Baseline to Day 28
K-877 PK Parameters AUC (Tau)	Day 28
Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)	Baseline to Day 28
Percentage Change From Baseline to Day 28 in Non-HDL-C	Baseline to Day 28
Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)	Baseline to Day 28
Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)	Baseline to Day 28
K-877 PK Parameters Cmax	Day 28	Observed maximum measured plasma concentration (Cmax)

Trial Locations

Locations (12)

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Aventiv Research, Inc.; 🇺🇸 Columbus, Ohio, United States

Prism Research; 🇺🇸 Saint Paul, Minnesota, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Medpace Clinical Pharmacology, LLC; 🇺🇸 Cincinnati, Ohio, United States

Summit Research Group, LLC; 🇺🇸 Munroe Falls, Ohio, United States

Manassas Clinical Research Center; 🇺🇸 Manassas, Virginia, United States

Columbus Regional Health; 🇺🇸 Columbus, Georgia, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

Health Concepts; 🇺🇸 Rapid City, South Dakota, United States

Diabetes and Endocrinology Consultants, P.C.; 🇺🇸 Morehead City, North Carolina, United States