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Completed

NCT Number: NCT04447820

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

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).

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-877-ER (Dose A)

Drug

Dose A Oral Administration

K-877-ER (Dose B)

Drug

Dose B Oral Administration

K-877-IR

Drug

K-877-IR Oral Administration

Primary outcomes

  1. Estimated Percentage Change in Fasting Triglyceride(s) (TG)

    Time frame: Baseline to Day 28

Secondary outcomes

  1. Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)

    Time frame: Baseline to Day 28

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

    Time frame: Baseline to Day 28

  3. Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline to Day 28

  4. Percentage Change From Baseline to Day 28 in Remnant Cholesterol

    Time frame: Baseline to Day 28

  5. Percentage Change From Baseline to Day 28 in Non-HDL-C

    Time frame: Baseline to Day 28

  6. Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)

    Time frame: Baseline to Day 28

  7. K-877 PK Parameters Cmax

    Time frame: Day 28

    Observed maximum measured plasma concentration (Cmax)

  8. K-877 PK Parameters AUC (Tau)

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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