NCT06955104

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

March 17, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

April 3, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

March 17, 2025

Last Update Submit

September 2, 2025

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in LDL-C

    Check LDL-C

    Week 8

Secondary Outcomes (1)

  • Efficacy and Safety: Change from baseline in LDL-C (mg/dL)

    Week 8

Study Arms (2)

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

JW0108 + C2407DRUG

JW0108 + C2407

Experimental Group: JW0108 + C2407
JW0108 + C2407 placeboDRUG

JW0108 + C2407 placebo

Control Group: JW0108 + C2407 placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

May 2, 2025

Study Start

April 3, 2025

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

September 3, 2025

Record last verified: 2025-09

Locations

KR(1)