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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

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
GroupInterventionDescription
K-877-ER Dose BK-877-ER (Dose B)K-877-ER dose B administered once daily
K-877-IRK-877-IRK-877-IR administered twice daily.
K-877-ER Dose AK-877-ER (Dose A)K-877-ER dose A administered once daily
Primary Outcome Measures
NameTimeMethod
Estimated Percentage Change in Fasting Triglyceride(s) (TG)Baseline to Day 28
Secondary Outcome Measures
NameTimeMethod
Percentage Change From Baseline to Day 28 in Remnant CholesterolBaseline 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-CBaseline 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 CmaxDay 28

Observed maximum measured plasma concentration (Cmax)

Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)Baseline to Day 28

Trial Locations

Locations (12)

Pinnacle Research Group

🇺🇸

Anniston, Alabama, United States

Jacksonville Center for Clinical Research

🇺🇸

Jacksonville, Florida, United States

Progressive Medical Research

🇺🇸

Port Orange, Florida, United States

Columbus Regional Health

🇺🇸

Columbus, Georgia, United States

Prism Research

🇺🇸

Saint Paul, Minnesota, United States

Diabetes and Endocrinology Consultants, P.C.

🇺🇸

Morehead City, North Carolina, United States

Medpace Clinical Pharmacology, LLC

🇺🇸

Cincinnati, Ohio, United States

Aventiv Research, Inc.

🇺🇸

Columbus, Ohio, United States

Summit Research Group, LLC

🇺🇸

Munroe Falls, Ohio, United States

Health Concepts

🇺🇸

Rapid City, South Dakota, United States

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Pinnacle Research Group
🇺🇸Anniston, Alabama, United States

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