- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382778
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without Diabetes (VICTORY)
January 27, 2026 updated by: JW Pharmaceutical
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
Study Overview
Status
Completed
Conditions
Detailed Description
A Multi-center, Open-label, Observational Study
Study Type
Observational
Enrollment (Actual)
1538
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, South Korea, 13496
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Contraindications to Livalozet®
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline in LDL-C level at Week 24
Time Frame: From enrollment to the end of treatment at 24 weeks
|
From enrollment to the end of treatment at 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2022
Primary Completion (Actual)
June 13, 2025
Study Completion (Actual)
June 13, 2025
Study Registration Dates
First Submitted
January 27, 2026
First Submitted That Met QC Criteria
January 27, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 27, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JW21403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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