A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequa… (NCT07634484) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins
120 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage change from baseline in LDL-C (direct)
Timeframe: 4, 8, and 12 weeks after administration