A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

JS002-006

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy. In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ). Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.

2022-02-28

2023-02-09

2023-02-09

Completed

Early phase I

255

Inclusion Criteria: 1. Signed informed consent. 2. Age 18\~80 years old; 3. Stable optimized LLT at least 4 weeks before randomization; 4. Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening; Exclusion Criteria: 1. History of NYHA class III-IV heart failure or EF\<30%; 2. History of uncontrolled arrhythmia within 90 days; 3. History of MI,UA, PCI or CABG, stroke within 90 days; 4. Known hemorrhagic stroke disease; 5. Planned cardiac surgery or revascularization. 6. Uncontrolled hypertension. 7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）. 8. Other conditions that the researchers considered inappropriate to participate in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 255, 'type': 'ACTUAL'}}

2023-03-15