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

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.

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

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.

Clinical Trials on Hypercholesterolemia

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