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Ongericimab (JS002) in Primary Hypercholesterolemia and Mixed Hyperlipidemia
NCT05532800Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Feb 2023
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- ongericimab
- Conditions
- hypercholesterolemiamixed hyperlipidemia
01
Overview
Phase 3, randomised, double-blind trial of ongericimab in hypercholesterolemia and mixed hyperlipidemia (4 arms), sponsored by Shanghai Junshi Biosciences Co., Ltd. Primary endpoint: Low-Density Lipoprotein Cholesterol at 12 weeks. Started Feb 2022; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
JS002 PFS
Ongericimab 150 mg Q2W via Prefilled Syringe + Statin
Placebo PFS
Placebo Q2W via Prefilled Syringe + Statin
JS002 AI
Ongericimab 150 mg Q2W via Autosyringe + Statin
Placebo AI
Placebo Q2W via Autosyringe + Statin
03
Who it enrols
Patients with primary hypercholesterolemia or mixed hyperlipidemia on stable optimized lipid-lowering therapy (statin). Excludes patients with NYHA III-IV heart failure, LVEF < 30%, recent MI/stroke/revascularization (within 90 days), uncontrolled hypertension, or uncontrolled diabetes (HbA1c > 8.0%).
04
Endpoints
Primary
Low-Density Lipoprotein Cholesterol
Secondary
Lipid parameters
LDL-C reduction >= 50%
LDL-C < 70 mg/dL
Full dose
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