Actively Recruiting
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2024-09-19
582
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 to 80 years old
- LDL cholesterol goal not achieved according to cardiovascular risk at screening
- Fasting triglycerides less than or equal to 4.5 mmol/L at screening
- History of statin intolerance if applicable
You will not qualify if you...
- History of hemorrhagic stroke
- New York Heart Association class III or IV heart failure, or left ventricular ejection fraction less than 30% within 1 year before randomization
- Uncontrolled serious cardiac arrhythmia within 90 days prior to randomization
- Heart attack, unstable angina, coronary intervention, stroke, deep vein thrombosis, or pulmonary embolism within 90 days prior to randomization
- Planned cardiac surgery or revascularization
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), or newly diagnosed type 2 diabetes within 90 days of randomization
- Other factors judged unsuitable by the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
Q
Qiu'e Wan, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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