Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Primary Hypercholesterolaemia and Mixed Dyslipidemia
About this trial
This is an interventional treatment trial for Primary Hypercholesterolaemia and Mixed Dyslipidemia
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age 18~80 years old Subject who has not achieve LDL-C goal as categorized by their CV risk at screening Fasting TG≤4.5mmol/L by central laboratory at screening Statin intolerance subject must have a history of statin intolerance as evidenced Exclusion Criteria: History of hemorrhagic stroke NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization Planned cardiac surgery or revascularization Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization) Others factors not suitable for participation judged by PI
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
JS002 150mg Q2W
JS002 450mg Q4W
Placebo Q2W
Placebo Q4W
JS002 150mg Q2W SC for 52 weeks
JS002 450mg Q4W SC for 52 weeks
Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks
Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks