HypercholesterolemiaVICTORYNCT07382778
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without Diabetes
An observational study of Hypercholesterolemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® according to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 1,538 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2022to 13 Jun 2025
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Participants will be selected from adult patients aged 19 years or older diagnosed with hypercholesterolemia who are receiving routine clinical care at participating centers. The population includes both patients with and without diabetes mellitus, reflecting real-world treatment practices. Eligible patients must provide informed consent to participate in this observational study.
Who may be able to join
- Men and women aged ≥19 years
- Diagnosed with hypercholesterolemia
- LDL-C level meets cardiovascular/cerebrovascular risk group classification
- Willing to participate for 12 months
- Provided written informed consent
Who cannot join
- Contraindications to Livalozet®
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13496
About this study
Official title: A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® According to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients
A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® according to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients
Read the detailed description
A Multi-center, Open-label, Observational Study
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, Diabetes Mellitus, Low Density Lipoprotein Cholesterol, Lipid Profile, Observational Study
- Medical subject headings
- Hypercholesterolemia, Diabetes Mellitus
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 |
|---|---|---|
| Hypercholesterolemia with Diabetes Mellitus | Observational study; LDL-C and lipid parameters will be followed; no intervention assigned. | |
| Hypercholesterolemia without Diabetes Mellitus | Observational study; LDL-C and lipid parameters will be followed; no intervention assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in LDL-C level at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start19 Oct 2022
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 1,538 participants (actual)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382778
- Sponsor's protocol ID
- JW21403
- Acronym
- VICTORY
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® According to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients
- ClinicalTrials.gov ID
- NCT07382778
- Acronym / sponsor ID
- VICTORY / JW21403
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, Diabetes Mellitus, Low Density Lipoprotein Cholesterol, Lipid Profile, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,538 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 3 Feb 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.
A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® according to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients
Detailed description
A Multi-center, Open-label, Observational Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypercholesterolemia with Diabetes Mellitus | – | –Observational study; LDL-C and lipid parameters will be followed; no intervention assigned. |
| Hypercholesterolemia without Diabetes Mellitus | – | –Observational study; LDL-C and lipid parameters will be followed; no intervention assigned. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from adult patients aged 19 years or older diagnosed with hypercholesterolemia who are receiving routine clinical care at participating centers. The population includes both patients with and without diabetes mellitus, reflecting real-world treatment practices. Eligible patients must provide informed consent to participate in this observational study.
Key inclusion criteria (5 listed)
- Men and women aged ≥19 years
- Diagnosed with hypercholesterolemia
- LDL-C level meets cardiovascular/cerebrovascular risk group classification
- Willing to participate for 12 months
- Provided written informed consent
Key exclusion criteria (1 listed)
- Contraindications to Livalozet®
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
Percent change from baseline in LDL-C level at Week 24
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypercholesterolemia, 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 1 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: finished, as of the sponsor's last update on 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in LDL-C level at Week 24 (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.