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

NCT05970679 | Completed Phase 3

• 1 other identifier: DW1125-301
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia, Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• % Change of LDL-C

  % Change of LDL-C in week 8 from baseline

  8 weeks

Secondary Outcomes (3)

• % Change of LDL-C

  4 weeks

• % Change of Lipid parameters

  4 weeks and 8 weeks

• LDL-C goal achievement rates

  4 weeks and 8 weeks

Study Arms (4)

DW1125

EXPERIMENTAL

1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily

Drug: Ezetimibe/Atorvastatin 10/5 mg; Drug: DW1125A placebo; Drug: DW1125E placebo; Drug: DW1125A-1 placebo

DW1125A

EXPERIMENTAL

1 Atorvastatin 5 mg tablet orally once daily

Drug: Atorvastatin 5mg; Drug: DW1125 placebo; Drug: DW1125E placebo; Drug: DW1125A-1 placebo

DW1125E

PLACEBO COMPARATOR

1 Ezetimibe 10mg tablet orally once daily

Drug: Ezetimibe 10mg; Drug: DW1125 placebo; Drug: DW1125A placebo; Drug: DW1125A-1 placebo

DW1125A-1

PLACEBO COMPARATOR

1 Atorvastatin 10mg tablet orally once daily

Drug: Atorvastatin 10mg; Drug: DW1125 placebo; Drug: DW1125A placebo; Drug: DW1125E placebo

Interventions

Ezetimibe/Atorvastatin 10/5 mg DRUG

DW1125

DW1125

Atorvastatin 5mg DRUG

DW1125A

DW1125A

Ezetimibe 10mg DRUG

DW1125E

Also known as: Ezetrol Tab. 10mg

DW1125E

Atorvastatin 10mg DRUG

DW1125A-1

Also known as: Lipiwon Tab. 10mg

DW1125A-1

DW1125 placebo DRUG

Ezetimibe/Atorvastatin 10/5 mg placebo

DW1125A; DW1125A-1; DW1125E

DW1125A placebo DRUG

Atorvastatin 5mg placebo

DW1125; DW1125A-1; DW1125E

DW1125E placebo DRUG

Ezetimibe 10mg placebo

DW1125; DW1125A; DW1125A-1

DW1125A-1 placebo DRUG

Atorvastatin 10mg placebo

DW1125; DW1125A; DW1125E

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 17, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

KR (1)