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

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ClinicalTrials.gov Identifier: NCT05923281
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Kowa Company, Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: K-877 0.2 mg/day (once daily) Drug: K-877 0.4 mg/day (once daily) Drug: Placebo (once daily) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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-
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A
K-877 0.2 mg/day
 Drug: K-877 0.2 mg/day (once daily)
K-877 0.2mg tablet
Other Name: Pemafibrate 0.2mg/day (once daily)
Experimental: Treatment B
K-877 0.4 mg/day
 Drug: K-877 0.4 mg/day (once daily)
K-877 0.2mg tablet
Other Name: Pemafibrate 0.4mg/day (once daily)
Placebo Comparator: Control A
Placebo
 Drug: Placebo (once daily)
Placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline in LDL-C (formula F). [ Time Frame: 4, 8, and 12 weeks after administration ]
    Percent change = (measured value at each time point - baseline value) / baseline value


Secondary Outcome Measures :
  1. Efficacy: % change from baseline in fasting serum LDL-C (mg/dL)(Direct) [ Time Frame: 4, 8, and 12 week after administration ]
  2. Efficacy: % change from baseline in fasting serum HDL-C (mg/dL) [ Time Frame: 4, 8, and 12 week after administration ]
  3. Efficacy: % change from baseline in fasting serum non HDL-C (mg/dL) [ Time Frame: 4, 8, and 12 week after administration ]
  4. Efficacy: % change from baseline in fasting serum TG (mg/dL) [ Time Frame: 4, 8, and 12 week after administration ]
  5. Efficacy: % change from baseline in fasting serum LDL-C（formula F）/HDL-C [ Time Frame: 4, 8, and 12 week after administration ]
  6. Efficacy: % change from baseline in fasting serum non HDL-C/HDL-C [ Time Frame: 4, 8, and 12 week after administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: The person who meet all the following criteria the object to the clinical trial

  1. Patients had to be age 18 years or older at written informed consent
  2. Patients with statin intolerant hypercholesterolemia
  3. Patients who have laboratory records with fasting serum TG <= 150 mg/dL (<=175 mg/dL when not fasting) within 6 months prior to consent.
  4. Patients with the fasting serum TG <= 150 mg/dL at screening
  5. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening

  6. 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.

  1. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
  2. Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
  3. Patients with uncontrolled thyroid disease
  4. Patients with undergoing LDL apheresis
  5. Patients with cirrhosis or those with biliary obstruction
  6. Patients with familial hypercholesterolemia (homozygotes)
  7. Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) at Screening
  8. Patients with an AST or ALT three times the upper limit at Screening
  9. Patients with an CK four times the upper limit at Screening
  10. 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
  11. Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization
  12. Patients with heart failure class III or higher according to NYHA cardiac function classification
  13. Patients with malignant tumor or those who are judged to have a high risk of recurrence
  14. Patients with a history of myopathy or rhabdomyolysis due to K-877 (pemafibrate)
  15. Patients with a history of hypersensitivity due to K-877 (pemafibrate)
  16. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
  17. 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
  18. 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
  19. Patients with alcoholics or drug addicts
  20. 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

  21. 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923281


Contacts
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Contact: Saito Ayumi 81-3-3279-7454 ctrdinfo@kowa.co.jp

Locations
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Japan
Nakayama Clinic Recruiting
Aichi, Japan
Kohnodai Hospital, National Center for Global Health and Medicine Recruiting
Chiba, Japan
Tashiro Endocrinology Clinic Recruiting
Fukuoka, Japan
NTT Medical Center Sapporo Recruiting
Hokkaido, Japan
Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital Recruiting
Ibaraki, Japan
Yokohama Minami Kyosai Hospital Recruiting
Kanagawa, Japan
Medical Corporation LONGWOOD Maeda Clinic Recruiting
Osaka, Japan
OCROM Clinic Recruiting
Osaka, Japan
Rinku General Medical Center Recruiting
Osaka, Japan
Koshigaya Municipal Hospital Recruiting
Saitama, Japan
Saitama Medical University Hospital Recruiting
Saitama, Japan
Affiliated CENTRAL CLINIC of Higashiyamato Hospital Recruiting
Tokyo, Japan
Medical Corporation Chiseikai Tokyo Center Clinic Recruiting
Tokyo, Japan
Mishuku Hospital Recruiting
Tokyo, Japan
ToCROM Clinic Recruiting
Tokyo, Japan
Sponsors and Collaborators
Kowa Company, Ltd.
More Information
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Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT05923281    
Other Study ID Numbers: K-877-ER-04
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases