Fixed-dose pitavastatin/ezetimibe for adults with dyslipidemia and metabolic syndrome

A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe Tablets in Patients With Dyslipidemia Who Also Have Metabolic Syndrome

This will try a fixed-dose pitavastatin/ezetimibe pill in adults with dyslipidemia and metabolic syndrome to see if it lowers LDL cholesterol and is safe over 48 weeks.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: JW Pharmaceutical (Industry-sponsored)
• Locations: 1 site (Daejeon)
• Trial ID: NCT07523971 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label observational study enrolling adults diagnosed with dyslipidemia who meet criteria for metabolic syndrome and who are prescribed pitavastatin/ezetimibe (2/10 mg or 4/10 mg) as part of routine care. No treatment is assigned by the protocol; investigators will treat patients according to usual practice and the study will record outcomes at baseline, 24 weeks and 48 weeks. The primary outcome is percent change in LDL-C from baseline to 24 weeks, with secondary lipid endpoints and the proportion reaching LDL-C targets at 24 and 48 weeks. Safety will be monitored by recording adverse events and serious adverse events throughout the 48-week observation period.

Who should consider this trial

Good fit: Adults (≥19 years) with dyslipidemia who meet metabolic syndrome criteria and who are being prescribed or considered for pitavastatin/ezetimibe, including those with inadequate response to prior lipid therapy or who have been off lipid regulators for at least 4 weeks, are the ideal candidates.

Not a fit: Patients with contraindications to pitavastatin/ezetimibe, those already well controlled on other lipid-lowering regimens, or those unable to attend follow-up visits are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, the fixed-dose pitavastatin/ezetimibe pill could lower LDL cholesterol more effectively than current regimens and simplify treatment for patients with metabolic syndrome.

How similar studies have performed: Randomized and observational studies of statin plus ezetimibe combinations have consistently shown additional LDL-C lowering, so this approach is supported overall though specific fixed-dose pitavastatin/ezetimibe data are less extensive.

Eligibility criteria

Inclusion Criteria:

1. Age 19 years old at the time of written informed consent
2. Subjects diagnosed with dyslipidemia and metabolic syndrome
3. Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration
4. Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups\* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator
5. Subjects who voluntarily sign the informed consent form for study participation

Exclusion Criteria:

1. Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
2. Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study
3. Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator

Where this trial is running

Daejeon

• Chungnam National University Hospita — Daejeon, South Korea (Recruiting)

Study contacts

• Study coordinator: Eunju Kim

Conditions Dyslipidemias; Metabolic Syndrome