Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study (PIVOT)

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

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin/Ezetimibe tablets (a fixed-dose combination of Pitavastatin and Ezetimibe) in patients with dyslipidemia who also have metabolic syndrome in a real-world clinical setting.

As this is an observational study, participants will be treated according to the investigator's medical judgment and routine clinical practice. The study aims to observe the changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 24 weeks and 48 weeks of treatment. Safety will also be assessed by monitoring any adverse events occurring during the 48-week observation period.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias

Detailed Description

This is a multi-center, open-label, prospective observational study designed to collect real-world evidence on the efficacy and safety of Pitavastatin/Ezetimibe tablets (2/10 mg and 4/10 mg). The study population consists of adult patients with dyslipidemia who satisfy the criteria for metabolic syndrome.

Key study procedures and objectives include:

Treatment: Participants who are prescribed Pitavastatin/Ezetimibe tablets as part of their routine care will be enrolled. No experimental intervention or forced treatment allocation will be performed.

Efficacy Evaluation: The primary endpoint is the percentage change in LDL-C levels from baseline (Visit 1) to 24 weeks (Visit 2). Secondary endpoints include changes in other lipid parameters (Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, Apo B) and the percentage of patients reaching their target LDL-C levels at 24 and 48 weeks.

Safety Evaluation: All adverse events (AEs) and serious adverse events (SAEs) will be recorded and analyzed to assess the safety profile of the study drug in this specific patient population.

Duration: Each participant will be observed for a total of 48 weeks, with visits occurring at baseline, 24 weeks, and 48 weeks.

The results of this study are expected to provide clinical insights into the long-term management of dyslipidemia in patients with multiple metabolic risk factors using a pitavastatin/ezetimibe combination.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: EUNJU KIM; Phone Number: 82-2-840-6983; Email: kej@jwhealthcare.com

Study Locations

• South Korea
  • Daejeon, South Korea
    • Recruiting
    • Chungnam National University Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Dyslipidemia Who Also Have Metabolic Syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pitavastatin/Ezetimibe Group; Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and Ezetimibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change	Percentage change in LDL-C levels from baseline	24 weeks

Collaborators and Investigators

• Sponsor: JW Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metabolic Syndrome
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: JW25403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect the privacy of study participants and to maintain the confidentiality of proprietary information belonging to the sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No