drugset / Trial / NCT04289285
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects
Timeline
- Start
- 2020-04-29
- Primary completion
- 2022-02-09
- Completion
- 2022-02-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafolecimab | Monoclonal antibody | 450 mg | Subcutaneous |
| Subject | Tafolecimab | Monoclonal antibody | 600 mg | Subcutaneous |