The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
NCT ID: NCT05532800
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2022-02-28
2023-02-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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JS002
Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI
JS002
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
Placebo
Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI
Placebo
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
Interventions
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JS002
JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.
Placebo
JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
Eligibility Criteria
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Inclusion Criteria
2. Age 18\~80 years old;
3. Stable optimized LLT at least 4 weeks before randomization;
4. Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;
Exclusion Criteria
2. History of uncontrolled arrhythmia within 90 days;
3. History of MI,UA, PCI or CABG, stroke within 90 days;
4. Known hemorrhagic stroke disease;
5. Planned cardiac surgery or revascularization.
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
8. Other conditions that the researchers considered inappropriate to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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Beijing Anzhen Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Daqing People's Hospital
Daqing, Heilongjiang, 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
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Nanchang First Hospital
Nanchang, Jiangxi, China
Nanchang Third Hospital
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Taizhou Hospital Of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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JS002-006
Identifier Type: -
Identifier Source: org_study_id
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