Pemafibrate in people with high cholesterol not fully controlled by statins
Official title: A Post-Marketing Clinical Trial of Pemafibrate in Patients With Hypercholesterolemia and Inadequate Response to Statins-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial
Run by Kowa Company, Ltd. · NCT07634484 · Data updated 2026-11-12
This study tests whether taking Pemafibrate at 0.2 mg or 0.4 mg daily for 12 weeks helps people with high cholesterol who still don’t respond well to statins, compared with a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Kowa Company, Ltd. Industry-sponsored |
| Locations | 10 sites (Hokkaido and 9 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07634484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with hypercholesterolemia who are on a stable statin regimen, have stable diet/exercise, and meet specific triglyceride and LDL-C criteria.
✕Probably not a fit
Patients who do not experience lipid improvement with Pemafibrate or who experience safety concerns may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 4 interventional trial evaluating the efficacy and safety of Pemafibrate at two daily doses (0.2 mg and 0.4 mg) versus placebo over 12 weeks in adults with hypercholesterolemia who have not achieved adequate lipid control on statins. Eligible participants must have stable lifestyle therapy, reduced triglycerides, and elevated LDL-C risk categories as defined by JAS2022 criteria. The study is conducted at multiple sites in Japan, led by Kowa Company with no listed collaborators. Primary endpoints likely focus on lipid changes and safety signals, with a placebo control to determine the added benefit of Pemafibrate after statin therapy. Enrollment targets and detailed protocol are not provided in the description.
Why it matters
Potential benefit: If successful, Pemafibrate could further improve lipid profiles and reduce cardiovascular risk in patients who do not reach goals with statins alone.
How similar studies have gone: Previous trials of Pemafibrate have shown lipid-lowering effects; this study extends to a post-marketing context with statin-intolerant or incompletely controlled patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:Patients who meet all the following criteria shall be eligible for the clinical trial.
1. Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent
2. 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.
3. Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.
4. Patients with the fasting serum TG \< 150 mg/dL on two consecutive occasions at screening
5. 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.
Exclusion Criteria:Patients who meet any of the following criteria will be excluded from the clinical trial.
1. Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent
2. Patients with type 1 diabetes and uncontrolled type 2 diabetes \[HbA1c(NGSP) \>= 10.0 % at Screening\]
3. Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.
4. Patients with uncontrolled thyroid disease
5. Patients who are undergoing or are scheduled to undergo LDL apheresis
6. Patients with cirrhosis or those with biliary obstruction
7. Patients with gallstones
8. Patients with familial hypercholesterolemia (homozygotes)
9. Patients with impaired renal function (eGFR \< 30 mL/min/1.73 m2 at screening)
10. Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg) at screening
11. Patients with AST and ALT levels three times or greater than the upper limit of normal at screening
12. Patients with CK levels at least three times the upper limit of normal at screening
13. 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
14. Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization
15. Patients with heart failure class III or higher according to NYHA cardiac function classification
16. Patients with malignant tumor or those who are judged to have a high risk of recurrence
17. Patients with a history of myopathy or rhabdomyolysis due to pemafibrate
18. Patients with a history of hypersensitivity due to pemafibrate
19. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
20. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women of childbearing potential\*2 who do not use specific contraceptive methods\*1
21. Patients who have undergone whole blood donation of 400 mL or more within 16 weeks, or 200 mL or more within 4 weeks, or component donation (plasma or platelet donation) within 2 weeks prior to screening.
22. Patients with alcoholics or drug addicts
23. 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
24. Patients who are considered inappropriate for participation in this study by the investigator, etc
* 1 Acceptable contraceptive methods: Oral hormonal contraceptives (combination pills containing progestin and estrogen), intrauterine devices, intrauterine hormonal delivery systems, abstinence
* 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 have passed more than 1 year since their last menstrual period without other medical reasons).
Where it's running
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NTT Medical Center Sapporo
Hokkaido, Japan Recruiting -
Ami Higashi Clinic
Ibaraki, Japan Recruiting -
Olive Takamatsu Medical Clinic
Kagawa, Japan Recruiting -
Medical Corporation Shintokai Yokohama Minoru Clinic
Kanagawa, Japan Recruiting -
Medical Corporation Heishinkai OCROM Clinic
Osaka, Japan Recruiting -
Hirose Clinic
Saitama, Japan Recruiting
Show 4 more locations
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Medical Corporation Yukeikai Asano Internal Medicine Clinic
Saitama, Japan Recruiting -
Medical Corporation Asbo Tokyo Asbo Clinic
Tokyo, Japan Recruiting -
Medical Corporation Heishinkai ToCROM Clinic
Tokyo, Japan Recruiting -
Shimokitazawa Tomo Clinic
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Kaho Ikegami
- Email: ctrdinfo@kowa.co.jp
- Phone: 81-3-3279-7454
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.