Efficacy and Safety of Livalozet® in Hypercholesterolemic... | NCT07382778

Studies
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without Diabetes

NCT07382778

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Feb 3, 2026Actual

Enrollment

1,538Actual

Phase

Not provided

Conditions

Hypercholesterolemia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2022Actual

Primary Completion Date

Jun 13, 2025Actual

Completion Date

Jun 13, 2025Actual

First Submitted Date

Jan 27, 2026

First Submission Date that Met QC Criteria

Jan 27, 2026

First Posted Date

Feb 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Feb 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

A Multi-center, Open-label, Observational Study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

48 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,538Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline in LDL-C level at Week 24		From enrollment to the end of treatment at 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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®

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13496	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided