Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia

A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia, Dyslipidemia
• Intervention / Treatment: Drug: Ezetimibe/Atorvastatin 10/5 mg; Drug: DW1125A placebo; Drug: DW1125E placebo; Drug: DW1125A-1 placebo; Drug: Atorvastatin 5mg; Drug: DW1125 placebo; Drug: Ezetimibe 10mg; Drug: Atorvastatin 10mg

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both gender, the person aged 19 or older
• Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia
• LDL- C ≤ 250 mg/dL and TG < 500 mg/dL on fasting status

Exclusion Criteria:

• Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1
• Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 on Visit 1
• Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1

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: DW1125; 1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily	Drug: Ezetimibe/Atorvastatin 10/5 mg; DW1125; Drug: DW1125A placebo; Atorvastatin 5mg placebo; Drug: DW1125E placebo; Ezetimibe 10mg placebo; Drug: DW1125A-1 placebo; Atorvastatin 10mg placebo
Experimental: DW1125A; 1 Atorvastatin 5 mg tablet orally once daily	Drug: DW1125E placebo; Ezetimibe 10mg placebo; Drug: DW1125A-1 placebo; Atorvastatin 10mg placebo; Drug: Atorvastatin 5mg; DW1125A; Drug: DW1125 placebo; Ezetimibe/Atorvastatin 10/5 mg placebo
Placebo Comparator: DW1125E; 1 Ezetimibe 10mg tablet orally once daily	Drug: DW1125A placebo; Atorvastatin 5mg placebo; Drug: DW1125A-1 placebo; Atorvastatin 10mg placebo; Drug: DW1125 placebo; Ezetimibe/Atorvastatin 10/5 mg placebo; Drug: Ezetimibe 10mg; DW1125E; Other Names: Ezetrol Tab. 10mg
Placebo Comparator: DW1125A-1; 1 Atorvastatin 10mg tablet orally once daily	Drug: DW1125A placebo; Atorvastatin 5mg placebo; Drug: DW1125E placebo; Ezetimibe 10mg placebo; Drug: DW1125 placebo; Ezetimibe/Atorvastatin 10/5 mg placebo; Drug: Atorvastatin 10mg; DW1125A-1; Other Names: Lipiwon Tab. 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Change of LDL-C	% Change of LDL-C in week 8 from baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Change of LDL-C	% Change of LDL-C in week 4 from baseline	4 weeks
% Change of Lipid parameters	% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs	4 weeks and 8 weeks
LDL-C goal achievement rates	LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: < 160 mg/dL, intermediate risk group: <130 mg/dL, high risk group: < 100 mg/dL, extreme risk group: < 70 mg/dL)	4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kim, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: DW1125-301

Drug and device information, study documents

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