Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Phase 3

• Conditions: Dyslipidemias
• Interventions: Drug: DWJ1177; Drug: DWJ1506; Drug: DWC202011; Drug: DWJ1507

• Registration Number: NCT04772443
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWJ1177	DWJ1177	-
DWJ1506	DWJ1506	-
DWC202011	DWC202011	-
DWJ1507	DWJ1507	-

Primary Outcome Measures

Name	Time	Method
LDL-C levels at week 8	Week 8	Change from baseline in LDL-C level at week 8 after administration of the IP