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

JRCT ID: jRCT2051230055

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypercholesterolemia
• Date of first enrollment: 18/07/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Placebo group: oral doses once daily
K-877 0.2 mg/day group: oral doses once daily
K-877 0.4 mg/day group: oral doses once daily

Outcome(s)

• Primary Outcome: Percent change from baseline in LDL-C (formula F) at 4, 8, and 12 weeks of treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

The person who meet any of the following criteria will be excluded from the study.
(1) Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
(2) Patients with uncontrolled thyroid disease
(3) Patients with undergoing LDL apheresis
(4) Patients with cirrhosis or those with biliary obstruction
(5) Patients with familial hypercholesterolemia (homozygotes)
(6) Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) at Screening
(7) Patients with an AST or ALT three times the upper limit at Screening
(8) Patients with an CK four times the upper limit at Screening
(9) 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
(10) Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization
(11) Patients with heart failure class III or higher according to NYHA cardiac function classification

Related Information

• Primary Sponsor: Tanigawa Ryohei