Evaluating JS002 for lowering cholesterol in patients with high cholesterol levels
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
This study is testing if a new drug called JS002 can help lower cholesterol levels in people with high cholesterol.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 582 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05621070 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the efficacy and safety of JS002, a monoclonal antibody targeting PCSK9, in patients with primary hypercholesterolaemia and mixed dyslipidemia. It is a randomized, double-blind, placebo-controlled study involving 582 participants who will be assigned to receive either JS002 or a placebo in two different dosage cohorts. The study includes a screening period, a 12-week double-blind treatment phase, a 40-week open-label treatment phase, and an 8-week follow-up period. The trial aims to evaluate not only the drug's effectiveness in lowering LDL cholesterol but also its safety and immunogenicity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have not achieved their LDL cholesterol goals despite treatment.
Not a fit: Patients with recent serious cardiovascular events or uncontrolled heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cholesterol management for patients with high cholesterol levels.
How similar studies have performed: Other studies have shown success with similar monoclonal antibody approaches for cholesterol management, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent 2. Age 18\~80 years old 3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening 4. Fasting TG≤4.5mmol/L by central laboratory at screening 5. Statin intolerance subject must have a history of statin intolerance as evidenced Exclusion Criteria: 1. History of hemorrhagic stroke 2. NYHA III or IV heart failure, or known LVEF\< 30% within 1 year before randomization 3. 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 4. 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 5. Planned cardiac surgery or revascularization 6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \> 160 mmHg or diastolic BP (DBP) \> 100 mmHg 7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization) 8. Others factors not suitable for participation judged by PI
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qiu'e Wan, PM
- Email: qiu.e_wan@junshipharma.com
- Phone: 86 17710342522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.