NCT07382778

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemiaDiabetes MellitusLow Density Lipoprotein CholesterolLipid ProfileObservational Study

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in LDL-C level at Week 24

    From enrollment to the end of treatment at 24 weeks

Study Arms (2)

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \- Contraindications to Livalozet®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

MeSH Terms

Conditions

HypercholesterolemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
48 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start

October 19, 2022

Primary Completion

June 13, 2025

Study Completion

June 13, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)