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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: IBI306 600mg SC Q6W; Other: Placebo SC Q6W; Drug: IBI306 450mg SC Q4W; Drug: Placebo SC Q4W

• Registration Number: NCT04289285
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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

Study Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2020-04-29
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI306 600mg SC Q6W	IBI306 600mg SC Q6W	-
Placebo SC Q6W	Placebo SC Q6W	-
IBI306 450mg SC Q4W	IBI306 450mg SC Q4W	-
Placebo SC Q4W	Placebo SC Q4W	-

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48	Week 48

Secondary Outcome Measures

Name	Time	Method
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)	Week 48
The percent of subjects with LDL-C reduction no less than 50% from baseline	Week 48
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline	Week 48

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China