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A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance

Primary Purpose

Hypercholesterolemia

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

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria: The person who meet all the following criteria the object to the clinical trial Patients had to be age 18 years or older at written informed consent Patients with statin intolerant hypercholesterolemia Patients who have laboratory records with fasting serum TG <= 150 mg/dL (<=175 mg/dL when not fasting) within 6 months prior to consent. Patients with the fasting serum TG <= 150 mg/dL at screening Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening Patients who apply any of the following risk category with LDL-C level (Friedewald formula) based on JAS2022 at screening Low risk for primary prevention: LDL-C >=160 mg/dL Intermediate risk for primary prevention: LDL-C >=140 mg/dL High risk for primary prevention: LDL-C>=120 mg/dL Secondary prevention: LDL-C>=120 mg/dL Exclusion Criteria: The person who meet any of the following criteria will be excluded from the study. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening] Patients with uncontrolled thyroid disease Patients with undergoing LDL apheresis Patients with cirrhosis or those with biliary obstruction Patients with familial hypercholesterolemia (homozygotes) Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) at Screening Patients with an AST or ALT three times the upper limit at Screening Patients with an CK four times the upper limit at Screening Patients with any of the following criteria within 3 months before obtaining informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, abdominal aortic aneurysm, uncontrolled severe arrhythmia and decompensated heart failure Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization 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 myopathy or rhabdomyolysis due to K-877 (pemafibrate) Patients with a history of hypersensitivity due to K-877 (pemafibrate) 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*2 who do not use specific contraceptive methods*1 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 with alcoholics or drug addicts Patients who participated in other clinical trials of a drug with new active ingredients within 16 weeks or a drug with an approved active ingredients within 12 weeks prior to administration and received an investigational drug other than placebo,or those who will participate in other clinical trials at the same time as the clinical trial Patients who have been determined inappropriate by the investigator, etc 1 Acceptable contraceptive methods: oral, implantable/injectable contraceptive hormones, mechanical products [intrauterine devices (IUDs) ,etc] or barrier methods with spermicides (pessaries, condoms, cervical caps, etc) 2 Woman of childbearing potential refers to a woman who is physiologically capable of becoming pregnant with a male partner who has not undergone contraception. However, it does not apply if the investigator confirms that any of the following criteria is met. Patients with hysterectomy or tubal ligation before informed consent Post-menopausal women (those who who have passed more than 1 year since their last menstrual period without other medical reasons).

Sites / Locations

  • Nakayama ClinicRecruiting
  • Kohnodai Hospital, National Center for Global Health and MedicineRecruiting
  • Tashiro Endocrinology ClinicRecruiting
  • NTT Medical Center SapporoRecruiting
  • Tsukuba Medical Center Foundation Tsukuba Medical Center HospitalRecruiting
  • Yokohama Minami Kyosai HospitalRecruiting
  • Medical Corporation LONGWOOD Maeda ClinicRecruiting
  • OCROM ClinicRecruiting
  • Rinku General Medical CenterRecruiting
  • Koshigaya Municipal HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • Affiliated CENTRAL CLINIC of Higashiyamato HospitalRecruiting
  • Medical Corporation Chiseikai Tokyo Center ClinicRecruiting
  • Mishuku HospitalRecruiting
  • ToCROM ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment A

Treatment B

Control A

Arm Description

K-877 0.2 mg/day

K-877 0.4 mg/day

Placebo

Outcomes

Primary Outcome Measures

Percent change from baseline in LDL-C (formula F).
Percent change = (measured value at each time point - baseline value) / baseline value

Secondary Outcome Measures

Efficacy: % change from baseline in fasting serum LDL-C (mg/dL)(Direct)
Efficacy: % change from baseline in fasting serum HDL-C (mg/dL)
Efficacy: % change from baseline in fasting serum non HDL-C (mg/dL)
Efficacy: % change from baseline in fasting serum TG (mg/dL)
Efficacy: % change from baseline in fasting serum LDL-C(formula F)/HDL-C
Efficacy: % change from baseline in fasting serum non HDL-C/HDL-C

Full Information

First Posted
June 20, 2023
Last Updated
June 20, 2023
Sponsor
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05923281
Brief Title
A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance
Official Title
A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Statin Intolerant Hypercholesterolemia-
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

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 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant* Hypercholesterolemia,using placebo as a controll. *Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
K-877 0.2 mg/day
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
K-877 0.4 mg/day
Arm Title
Control A
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
K-877 0.2 mg/day (once daily)
Other Intervention Name(s)
Pemafibrate 0.2mg/day (once daily)
Intervention Description
K-877 0.2mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 0.4 mg/day (once daily)
Other Intervention Name(s)
Pemafibrate 0.4mg/day (once daily)
Intervention Description
K-877 0.2mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo (once daily)
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Percent change from baseline in LDL-C (formula F).
Description
Percent change = (measured value at each time point - baseline value) / baseline value
Time Frame
4, 8, and 12 weeks after administration
Secondary Outcome Measure Information:
Title
Efficacy: % change from baseline in fasting serum LDL-C (mg/dL)(Direct)
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
Title
Efficacy: % change from baseline in fasting serum TG (mg/dL)
Time Frame
4, 8, and 12 week after administration
Title
Efficacy: % change from baseline in fasting serum LDL-C(formula F)/HDL-C
Time Frame
4, 8, and 12 week after administration
Title
Efficacy: % change from baseline in fasting serum non HDL-C/HDL-C
Time Frame
4, 8, and 12 week after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The person who meet all the following criteria the object to the clinical trial Patients had to be age 18 years or older at written informed consent Patients with statin intolerant hypercholesterolemia Patients who have laboratory records with fasting serum TG <= 150 mg/dL (<=175 mg/dL when not fasting) within 6 months prior to consent. Patients with the fasting serum TG <= 150 mg/dL at screening Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening Patients who apply any of the following risk category with LDL-C level (Friedewald formula) based on JAS2022 at screening Low risk for primary prevention: LDL-C >=160 mg/dL Intermediate risk for primary prevention: LDL-C >=140 mg/dL High risk for primary prevention: LDL-C>=120 mg/dL Secondary prevention: LDL-C>=120 mg/dL Exclusion Criteria: The person who meet any of the following criteria will be excluded from the study. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening] Patients with uncontrolled thyroid disease Patients with undergoing LDL apheresis Patients with cirrhosis or those with biliary obstruction Patients with familial hypercholesterolemia (homozygotes) Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) at Screening Patients with an AST or ALT three times the upper limit at Screening Patients with an CK four times the upper limit at Screening Patients with any of the following criteria within 3 months before obtaining informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, abdominal aortic aneurysm, uncontrolled severe arrhythmia and decompensated heart failure Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization 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 myopathy or rhabdomyolysis due to K-877 (pemafibrate) Patients with a history of hypersensitivity due to K-877 (pemafibrate) 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*2 who do not use specific contraceptive methods*1 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 with alcoholics or drug addicts Patients who participated in other clinical trials of a drug with new active ingredients within 16 weeks or a drug with an approved active ingredients within 12 weeks prior to administration and received an investigational drug other than placebo,or those who will participate in other clinical trials at the same time as the clinical trial Patients who have been determined inappropriate by the investigator, etc 1 Acceptable contraceptive methods: oral, implantable/injectable contraceptive hormones, mechanical products [intrauterine devices (IUDs) ,etc] or barrier methods with spermicides (pessaries, condoms, cervical caps, etc) 2 Woman of childbearing potential refers to a woman who is physiologically capable of becoming pregnant with a male partner who has not undergone contraception. However, it does not apply if the investigator confirms that any of the following criteria is met. Patients with hysterectomy or tubal ligation before informed consent Post-menopausal women (those who who have passed more than 1 year since their last menstrual period without other medical reasons).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saito Ayumi
Phone
81-3-3279-7454
Email
ctrdinfo@kowa.co.jp
Facility Information:
Facility Name
Nakayama Clinic
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kohnodai Hospital, National Center for Global Health and Medicine
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tashiro Endocrinology Clinic
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
NTT Medical Center Sapporo
City
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
City
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama Minami Kyosai Hospital
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation LONGWOOD Maeda Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
OCROM Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rinku General Medical Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Koshigaya Municipal Hospital
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Affiliated CENTRAL CLINIC of Higashiyamato Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mishuku Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
ToCROM Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance

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