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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05970679

Enrollment

252

Registered

2023-08-01

Start date

2022-08-17

Completion date

2023-04-13

Last updated

2023-08-01

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

Conditions

Hypercholesterolemia, Dyslipidemia

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

Interventions

DRUGDW1125A-1 placebo

Atorvastatin 10mg placebo

DRUGEzetimibe/Atorvastatin 10/5 mg

DW1125

DRUGAtorvastatin 5mg

DW1125A

DRUGEzetimibe 10mg

DW1125E

DRUGAtorvastatin 10mg

DW1125A-1

DRUGDW1125 placebo

Ezetimibe/Atorvastatin 10/5 mg placebo

DRUGDW1125A placebo

Atorvastatin 5mg placebo

DRUGDW1125E placebo

Ezetimibe 10mg placebo

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

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
% Change of LDL-C	4 weeks	% Change of LDL-C in week 4 from baseline
% Change of Lipid parameters	4 weeks and 8 weeks	% 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
LDL-C goal achievement rates	4 weeks and 8 weeks	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)

Countries

South Korea

Outcome results

None listed

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