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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: DWJ1506; Drug: DWJ1507; Drug: DWC202011; Drug: DWJ1177

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWJ1506	Drug: DWJ1506; DWJ1506
Experimental: DWJ1507	Drug: DWJ1507; DWJ1507
Active Comparator: DWC202011	Drug: DWC202011; DWC202011
Active Comparator: DWJ1177	Drug: DWJ1177; DWC202011

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: DW_DWJ1507301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No