Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04772443

Enrollment

280

Registered

2021-02-26

Start date

2021-02-28

Completion date

2022-12-31

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief summary

The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.

Interventions

DRUGDWJ1177

DWC202011

DRUGDWJ1506

DWJ1506

DRUGDWJ1507

DWJ1507

DRUGDWC202011

DWC202011

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults aged 19 years or over 2. Patients with LDL-C levels ≤ 250 mg/dL, TG \< 500 mg/dL 3. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion criteria

1. Severe congestive hear failure 2. Current active liver disease 3. The use of prohibiterd concomitant therapies 4. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
LDL-C levels at week 8	Week 8	Change from baseline in LDL-C level at week 8 after administration of the IP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026