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

NCT ID: NCT05923281

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-08-07

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

K-877 0.2 mg/day

Group Type: EXPERIMENTAL

K-877 0.2 mg/day (once daily)

Intervention Type: DRUG

K-877 0.2mg tablet

Treatment B

K-877 0.4 mg/day

Group Type: EXPERIMENTAL

K-877 0.4 mg/day (once daily)

Intervention Type: DRUG

K-877 0.2mg tablet

Control A

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo (once daily)

Intervention Type: DRUG

Placebo tablet

Interventions

K-877 0.2 mg/day (once daily)

K-877 0.2mg tablet

Intervention Type: DRUG

K-877 0.4 mg/day (once daily)

K-877 0.2mg tablet

Intervention Type: DRUG

Placebo (once daily)

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

Pemafibrate 0.2mg/day (once daily); Pemafibrate 0.4mg/day (once daily)

Eligibility Criteria

Inclusion Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nakayama Clinic

Aichi, , Japan

Kohnodai Hospital, National Center for Global Health and Medicine

Chiba, , Japan

Tashiro Endocrinology Clinic

Fukuoka, , Japan

Central Japan International Medical Center

Gifu, , Japan

NTT Medical Center Sapporo

Hokkaido, , Japan

Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital

Ibaraki, , Japan

Yokohama Minami Kyosai Hospital

Kanagawa, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Medical Corporation LONGWOOD Maeda Clinic

Osaka, , Japan

OCROM Clinic

Osaka, , Japan

Rinku General Medical Center

Osaka, , Japan

Koshigaya Municipal Hospital

Saitama, , Japan

Saitama Medical University Hospital

Saitama, , Japan

Affiliated CENTRAL CLINIC of Higashiyamato Hospital

Tokyo, , Japan

Fukuwa Clinic

Tokyo, , Japan

Juntendo University Hospital

Tokyo, , Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Tokyo, , Japan

Mishuku Hospital

Tokyo, , Japan

Seiwa Clinic

Tokyo, , Japan

ToCROM Clinic

Tokyo, , Japan

Tokyo Heart Summit Tokyo Heart Rhythm Hospital

Tokyo, , Japan

Tokyo-Eki Center-building Clinic

Tokyo, , Japan

Countries

Japan

Other Identifiers

K-877-ER-04

Identifier Type: -

Identifier Source: org_study_id