JS002 for High Cholesterol and Dyslipidemia
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
Recruiting
Phase 3
Interventional Study
Primary Hypercholesterolaemia and Mixed Dyslipidemia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 582 (estimated)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 80 with high cholesterol levels that are not well controlled. Participants will receive either the study drug JS002 or a placebo for a period of 12 weeks, followed by a longer treatment period.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 80 years old.
- I have not achieved my cholesterol goals.
- My fasting triglycerides are 4.5 mmol/L or lower.
- I have a history of not tolerating statins.
You may not be able to join if
- I have had a hemorrhagic stroke.
- I have severe heart failure or poor heart function.
- I have an uncontrolled serious heart rhythm problem.
- I have had a heart attack or stroke in the past 90 days.
- I have uncontrolled high blood pressure.
- I have type 1 diabetes or poorly controlled type 2 diabetes.
- I am scheduled for heart surgery.
- I have other factors judged by the doctor.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
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Eligibility 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 evidenc…
Contacts