A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins

NCT07634484 | Not Yet Recruiting Phase 4

• 1 other identifier: PALT03
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in LDL-C (direct)

  Percent change = (measured value at each time point - baseline value) / baseline value

  4, 8, and 12 weeks after administration

Secondary Outcomes (2)

• Achievement of lipid management targets based on the mean LDL-C (direct) values

  4, 8, and 12 weeks after administration

• Percentage change from baseline in LDL-C(Friedewald formula), HDL-C(direct), non-HDL-C, TC, TG

  4, 8, and 12 weeks after administration

Study Arms (3)

Pemafibrate 0.2mg/day

EXPERIMENTAL

Drug: Pemafibrate 0.2 mg/day

Pemafibrate 0.4mg/day

EXPERIMENTAL

Drug: Pemafibrate 0.4 mg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pemafibrate 0.2 mg/day DRUG

Administered orally once daily

Pemafibrate 0.2mg/day

Pemafibrate 0.4 mg/day DRUG

Administered orally once daily

Pemafibrate 0.4mg/day

Placebo DRUG

Administered orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent
• Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.
• Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.
• Patients with the fasting serum TG \< 150 mg/dL on two consecutive occasions at screening
• Patients who apply any of the following risk category with LDL-C level (direct) based on JAS2022 on two consecutive occasions 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 or 100 mg/dL\*
• Secondary prevention: LDL-C\>=100 mg/dL
• Familial hypercholesterolemia (heterozygous): LDL-C\>=100 mg/dL
• For patients with diabetes, those with peripheral artery disease (PAD), microvascular complications (retinopathy, nephropathy, neuropathy), or current smoking are included if LDL-C\>=100 mg/dL.

You may not qualify if:

• Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent
• Patients with type 1 diabetes and uncontrolled type 2 diabetes \[HbA1c(NGSP) \>= 10.0 % at Screening\]
• Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.
• Patients with uncontrolled thyroid disease
• Patients who are undergoing or are scheduled to undergo LDL apheresis
• Patients with cirrhosis or those with biliary obstruction
• Patients with gallstones
• Patients with familial hypercholesterolemia (homozygotes)
• Patients with impaired renal function (eGFR \< 30 mL/min/1.73 m2 at screening)
• Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg) at screening
• Patients with AST and ALT levels three times or greater than the upper limit of normal at screening
• Patients with CK levels at least three times the upper limit of normal at screening
• Patients with any of the following experiences within 3 months prior to 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Kaho Ikegami

CONTACT

81-3-3279-7454; ctrdinfo@kowa.co.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06