A Phase III Confirmatory Study of K-877 Extended Release Tablet

June 17, 2024 updated by: Kowa Company, Ltd.

A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanagawa, Japan
        • Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
      • Osaka, Japan
        • Medical Corporation Heishinkai OCROM Clinic
      • Tokyo, Japan
        • Medical Corporation Heishinkai ToCROM Clinic
      • Tokyo, Japan
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Tokyo, Japan
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Japan
        • Dojinkinenkai Meiwa Hospital
      • Tokyo, Japan
        • Fukuwa Clinic
      • Tokyo, Japan
        • Ikebukuro Metropolitan Clinic
      • Tokyo, Japan
        • Medical Corp. Seikoukai New Medical Research System Clinic
      • Tokyo, Japan
        • Medical Corporation Asbo Tokyo Asbo Clinic
      • Tokyo, Japan
        • Medical Corporation Yuhokai Miho Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with dyslipidemia had to be age 20 years or older at written informed consent
  2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
  3. Patients with the fasting serum TG >= 200 mg/dL twice consecutively at Screening

Exclusion Criteria:

  1. Patients with a fasting serum TG > 1000 mg/dL at Screening
  2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
  3. Patients with uncontrolled thyroid disease
  4. Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 8.0 % at Screening]
  5. Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
  6. Patients with an AST or ALT three times the upper limit at Screening
  7. Patients with an CK five times the upper limit at Screening
  8. Patients with cirrhosis or those with biliary obstruction
  9. Patients with acute myocardial infarction within 3 months before obtaining informed consent
  10. Patients with heart failure class III or higher according to NYHA cardiac function classification
  11. Patients with malignant tumor or those who are judged to have a high risk of recurrence
  12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
  13. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
  14. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
  15. Patients who have received K-877 (pemafibrate)
  16. Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
  17. Patients who have been determined inappropriate by the investigator, etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A
K-877 ER 0.2 mg/day (once daily)
Drug: K-877 ER 0.2 mg/day (once daily)
K-877 ER 0.2 mg tablet
Other Names:
  • Pemafibrate ER 0.2 mg/day (once daily)
Experimental: Treatment B
K-877 ER 0.4 mg/day (once daily)
Drug: K-877 ER 0.4 mg/day (once daily)
K-877 ER 0.4 mg tablet
Other Names:
  • Pemafibrate ER 0.4 mg/day (once daily)
Active Comparator: Control A
K-877 IR 0.2 mg/day (twice daily)
Drug: K-877 IR 0.2 mg/day (twice daily)
K-877 IR 0.1 mg tablet
Other Names:
  • Pemafibrate IR 0.2 mg/day (twice daily)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Efficacy : % change from baseline in fasting serum TG (mg/dL)
Time Frame: 4, 8, and 12 week after administration
4, 8, and 12 week after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)
Time Frame: 4, 8, and 12 week after administration
4, 8, and 12 week after administration
Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)
Time Frame: 4, 8, and 12 week after administration
4, 8, and 12 week after administration
Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)
Time Frame: 4, 8, and 12 week after administration
4, 8, and 12 week after administration
Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)
Time Frame: 4, 8, and 12 week after administration
4, 8, and 12 week after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kowa Company, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-877-ER-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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