Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS002, JS002, Placebo, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Hypercholesterolaemia and Mixed Dyslipidemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
Interventions
- Drug JS002
JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously. - Drug JS002
JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously. - Drug Placebo
Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously. - Drug Placebo
Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
Primary outcome measures
- Percent Change From Baseline in LDL-C at Week 12 [Time frame: Baseline and week 12]
- Percent Change From Baseline in LDL-C at Week 12 [Time frame: Baseline and week 12]
Secondary outcome measures (6)
- Change From Baseline in LDL-C at Week 12 [Time frame: Baseline and week 12]
- Percent Change From Baseline in LDL-C at Week 24,52 [Time frame: Baseline and week 24,52]
- Change From Baseline in LDL-C at Week 24,52 [Time frame: Baseline and week 24,52]
- Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52 [Time frame: Baseline and week 12, 24, 52]
- Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) [Time frame: Baseline and week 12, 24, 52]
- Percentage of Participants With Full Administration of JS002 [Time frame: Baseline and week 12, 24, 52]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Publications
- Shao C, Zhang S, Cheng Z, Yang K, Wang G, Shi X, Yang H, Ji Y, Li H, Zhang S, Ma J, Pei Z, Zhang Y, Li Y, Li L, Zheng Y, Shao C, Zhang M, Hao Y, Tang YD. Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Aug;407:120408. doi: 10.1016/j.atherosclerosis PMID 40543299
Identifiers
NCT: NCT05621070 · JS002-007