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

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).

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: K-877-ER (Dose A); Drug: K-877-ER (Dose B); Drug: K-877-IR

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Health
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, P.C.
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology, LLC
    • Columbus, Ohio, United States, 43213
      • Aventiv Research, Inc.
    • Munroe Falls, Ohio, United States, 44262
      • Summit Research Group, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-877-ER Dose A; K-877-ER dose A administered once daily	Drug: K-877-ER (Dose A); Dose A Oral Administration
Experimental: K-877-ER Dose B; K-877-ER dose B administered once daily	Drug: K-877-ER (Dose B); Dose B Oral Administration
Experimental: K-877-IR; K-877-IR administered twice daily.	Drug: K-877-IR; K-877-IR Oral Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimated Percentage Change in Fasting Triglyceride(s) (TG)	Baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)		Baseline to Day 28
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 High-density Lipoprotein Cholesterol (HDL-C)		Baseline to Day 28
Percentage Change From Baseline to Day 28 in Remnant Cholesterol		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
K-877 PK Parameters Cmax	Observed maximum measured plasma concentration (Cmax)	Day 28
K-877 PK Parameters AUC (Tau)		Day 28

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): December 3, 2020

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: K-877-ER-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No