NCT04289285

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

Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	IBI306 450mg SC Q4W	Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
DRUG	Placebo SC Q4W	Subjects will receive placebo every 4 weeks subcutaneously.
DRUG	IBI306 600mg SC Q6W	Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
OTHER	Placebo SC Q6W	Subjects will receive placebo every 6 weeks subcutaneously.

Timeline

• Start date: 2020-04-29
• Primary completion: 2022-02-09
• Completion: 2022-02-09
• First posted: 2020-02-28
• Last updated: 2022-04-11

Locations

1 site across 1 country: China