DyslipidemiasPIVOTNCT07523971
Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study
An observational study of Dyslipidemias, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2025to Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dyslipidemia Who Also Have Metabolic Syndrome
Who may be able to join
- Age 19 years old at the time of written informed consent
- Subjects diagnosed with dyslipidemia and metabolic syndrome
- 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
- 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
- Subjects who voluntarily sign the informed consent form for study participation
Who cannot join
- Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
- 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
- Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospita
Daejeon
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidemias
- Keywords
- Metabolic Syndrome
- Medical subject headings
- Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin/Ezetimibe Group | Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change
Percentage change in LDL-C levels from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523971
- Sponsor's protocol ID
- JW25403
- Acronym
- PIVOT
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Joung KH, Ku BJ. A multi-center, open-label, observational study to evaluate the efficacy and safety of LivaloZet(R) tablets in patients with dyslipidemia and metabolic syndrome: PIVOT study protocol. Front Endocrinol (Lausanne). 2026 Jul 10;17:1862394. doi: 10.3389/fendo.2026.1862394. eCollection 2026.
PubMed 42500128
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07523971
- Acronym / sponsor ID
- PIVOT / JW25403
- Conditions
- Dyslipidemias
- Keywords
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin/Ezetimibe Group | – | –Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and Ezetimibe |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dyslipidemia Who Also Have Metabolic Syndrome
Key inclusion criteria (5 listed)
- Age 19 years old at the time of written informed consent
- Subjects diagnosed with dyslipidemia and metabolic syndrome
- 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
- 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
- Subjects who voluntarily sign the informed consent form for study participation
Key exclusion criteria (3 listed)
- Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
- 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
- Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage change
Time frame: 24 weeks
Percentage change in LDL-C levels from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42500128Joung KH, Ku BJ. A multi-center, open-label, observational study to evaluate the efficacy and safety of LivaloZet(R) tablets in patients with dyslipidemia and metabolic syndrome: PIVOT study protocol. Front Endocrinol (Lausanne). 2026 Jul 10;17:1862394. doi: 10.3389/fendo.2026.1862394. eCollection 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EUNJU KIM (82-2-840-6983, kej@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07523971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.