The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
- Registration Number
- NCT05532800
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- Signed informed consent.
- Age 18~80 years old;
- Stable optimized LLT at least 4 weeks before randomization;
- Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;
- History of NYHA class III-IV heart failure or EF<30%;
- History of uncontrolled arrhythmia within 90 days;
- History of MI,UA, PCI or CABG, stroke within 90 days;
- Known hemorrhagic stroke disease;
- Planned cardiac surgery or revascularization.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitius (HbA1c>8.0%）.
- Other conditions that the researchers considered inappropriate to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JS002 JS002 Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI Placebo Placebo Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI
- Primary Outcome Measures
Name Time Method LDL-C with JS002 AI at week 12 Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI
LDL-C with JS002 PFS at week 12 Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS
- Secondary Outcome Measures
Name Time Method LDL-C with JS002 AI at week 12 The absolute change in LDL-C relative to baseline with JS002 AI
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 PFS at week 12 The absolute change in LDL-C relative to baseline with JS002 PFS
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
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)
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 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
Trial Locations
- Locations (21)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Daqing People's Hospital
🇨🇳Daqing, Heilongjiang, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, Shanxi, China
Taizhou Hospital Of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Beijing Anzhen Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
Changzhou Second People's Hospital
🇨🇳Changzhou, Jiangsu, China
Nanchang First Hospital
🇨🇳Nanchang, Jiangxi, China
Nanchang Third Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Dalian Municipal Central Hospital
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China