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

NCT04289285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2022-04-11

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2022-02-09
Completion
2022-02-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289285 on ClinicalTrials.gov