drugset / Trial / NCT04289285

Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

NCT04289285

Phase 3 Completed 804 enrolled Innovent Biologics (Suzhou) Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Tafolecimab Monoclonal antibody 450 mg Subcutaneous
Subject Tafolecimab Monoclonal antibody 600 mg Subcutaneous

Indications