Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia

Official Title
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A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: HGP1910
* Drug: HCP1903
* Drug: HGP1909
* Drug: HGP1911


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged ≥ 19 years Participants who have voluntarily given written consent to participate in this clinical trial Participants with LDL-C ≤ 250mg/dL and TG < 500mg/dL at Visit 1 Participants with LDL-C ≤ 250mg/dL, TG < 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC) Exclusion Criteria: Patients with active liver disease and severe liver impairment Patients with severe renal failure (eGFR < 30 mL/min/1.73 m2 at Visit 1) Patients with type I diabetes or uncontrolled type 2 diabetes Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1) Patients with symptomatic orthostatic hypotension Patients with NYHA class III IV heart failure, CCSA class III IV angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (TIAs), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before Visit 1. Patients who were diagnosed with a malignant tumor within five years before Visit.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HGP1910<br> | Drug: HGP1910<br>* Take it once daily for 8 weeks orally.<br>|
| Experimental: HCP1903<br> | Drug: HCP1903<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: HGP1909<br> | Drug: HGP1909<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: HGP1911<br> | Drug: HGP1911<br>* Take it once daily for 8 weeks orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change(%) from baseline in LDL-C at week 8 |  | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change(%) from baseline in LDL-C at week 4 |  | baseline, 4 weeks | 
| Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C |  | baseline, 4 weeks, 8 weeks | 
| Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a) |  | baseline, 4 weeks, 8 weeks | 
| Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category |  | baseline, 4 weeks, 8 weeks |