Clinical Trial to Evaluate the Efficacy and Safety of Co-... | NCT06955104

Studies
Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia

NCT06955104

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Sep 3, 2025Actual

Enrollment

145Actual

Phase

Phase 3

Conditions

Dyslipidemia

Interventions

JW0108 + C2407
JW0108 + C2407 placebo

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

Sep 2025

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

Apr 3, 2025Actual

Primary Completion Date

Jul 30, 2025Actual

Completion Date

Jul 30, 2025Actual

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Apr 30, 2025

First Posted Date

May 2, 2025Actual

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

Sep 2, 2025

Last Update Posted Date

Sep 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia

Detailed Description

To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group: JW0108 + C2407	Experimental	For 8weeks QD(Quaque Die)	Drug: JW0108 + C2407
Control Group: JW0108 + C2407 placebo	Active Comparator	For 8weeks QD(Quaque Die)	Drug: JW0108 + C2407 placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JW0108 + C2407	Drug	JW0108 + C2407	Experimental Group: JW0108 + C2407

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline in LDL-C	Check LDL-C	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Efficacy and Safety: Change from baseline in LDL-C (mg/dL)	Check LDL-C	Week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 19 years old at the time of written informed consent
Patients with dyslipidemia

Exclusion Criteria:

Secondary dyslipidemia
Patient who does not meet the specified TG, LDL-C level

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		05505	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided