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

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
K-877 ER 0.2 mg/day (once daily)
K-877 ER 0.4 mg/day (once daily)
K-877 IR 0.2 mg/day (twice daily)
Sponsored by
Kowa Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment A

Treatment B

Control A

Arm Description

K-877 ER 0.2 mg/day (once daily)

K-877 ER 0.4 mg/day (once daily)

K-877 IR 0.2 mg/day (twice daily)

Outcomes

Primary Outcome Measures

Efficacy : % change from baseline in fasting serum TG (mg/dL)

Secondary Outcome Measures

Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)
Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)
Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)
Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)

Full Information

First Posted
January 15, 2021
Last Updated
December 2, 2021
Sponsor
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04714151
Brief Title
A Phase III Confirmatory Study of K-877 Extended Release Tablet
Official Title
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-
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 25, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
K-877 ER 0.2 mg/day (once daily)
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
K-877 ER 0.4 mg/day (once daily)
Arm Title
Control A
Arm Type
Active Comparator
Arm Description
K-877 IR 0.2 mg/day (twice daily)
Intervention Type
Drug
Intervention Name(s)
K-877 ER 0.2 mg/day (once daily)
Other Intervention Name(s)
Pemafibrate ER 0.2 mg/day (once daily)
Intervention Description
K-877 ER 0.2 mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 ER 0.4 mg/day (once daily)
Other Intervention Name(s)
Pemafibrate ER 0.4 mg/day (once daily)
Intervention Description
K-877 ER 0.4 mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 IR 0.2 mg/day (twice daily)
Other Intervention Name(s)
Pemafibrate IR 0.2 mg/day (twice daily)
Intervention Description
K-877 IR 0.1 mg tablet
Primary Outcome Measure Information:
Title
Efficacy : % change from baseline in fasting serum TG (mg/dL)
Time Frame
4, 8, and 12 week after administration
Secondary Outcome Measure Information:
Title
Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)
Time Frame
4, 8, and 12 week after administration
Title
Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)
Time Frame
4, 8, and 12 week after administration
Title
Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)
Time Frame
4, 8, and 12 week after administration
Title
Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)
Time Frame
4, 8, and 12 week after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with dyslipidemia had to be age 20 years or older at written informed consent Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening Patients with the fasting serum TG >= 200 mg/dL twice consecutively at Screening Exclusion Criteria: Patients with a fasting serum TG > 1000 mg/dL at Screening Patients who require administration of prohibited drugs during the clinical trial period after written informed consent Patients with uncontrolled thyroid disease Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 8.0 % at Screening] Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) Patients with an AST or ALT three times the upper limit at Screening Patients with an CK five times the upper limit at Screening Patients with cirrhosis or those with biliary obstruction Patients with acute myocardial infarction within 3 months before obtaining informed consent Patients with heart failure class III or higher according to NYHA cardiac function classification Patients with malignant tumor or those who are judged to have a high risk of recurrence Patients with a history of serious drug allergies (anaphylactic shock, etc.) 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 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 Patients who have received K-877 (pemafibrate) 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 Patients who have been determined inappropriate by the investigator, etc
Facility Information:
Facility Name
Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
City
Kanagawa
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Osaka
Country
Japan
Facility Name
Dojinkinenkai Meiwa Hospital
City
Tokyo
Country
Japan
Facility Name
Fukuwa Clinic
City
Tokyo
Country
Japan
Facility Name
Ikebukuro Metropolitan Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corp. Seikoukai New Medical Research System Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corporation Asbo Tokyo Asbo Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corporation Yuhokai Miho Clinic
City
Tokyo
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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