Hyperlipemia
Conditions
Brief summary
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.
Interventions
DRUGJS002
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
DRUGPlacebo
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C with JS002 PFS | at week 12 | Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS |
| LDL-C with JS002 AI | at week 12 | Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid parameters | at week 12 | Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI |
| LDL-C reduction≥50 with JS002 PFS | at week 12 | Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline |
| LDL-C reduction≥50 with JS002 AI | at week 12 | Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline |
| LDL-C with JS002 PFS | at week 12 | The absolute change in LDL-C relative to baseline with JS002 PFS |
| LDL-C dropped to < 70 mg/dL with JS002 AI | at week 12 | Proportion of subjects whose serum LDL-C dropped to \< 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI |
| full dose | at week 0, 2, 4, 6, 8, 10 | Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10) |
| LDL-C dropped to < 70 mg/dL with JS002 PFS | at week 12 | Proportion of subjects whose serum LDL-C dropped to \< 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS |
| LDL-C with JS002 AI | at week 12 | The absolute change in LDL-C relative to baseline with JS002 AI |
Countries
China
Outcome results
None listed