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

Innovent Biologics

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo SC Q4W; Drug: IBI306 600mg SC Q6W; Other: Placebo SC Q6W; Drug: IBI306 450mg SC Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289285

CIBI306B301

Details and patient eligibility

About

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

Full 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

Enrollment: 804 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

1. Diagnosis of HoFH or HeFH
2. Uncontrolled hypertension
3. Uncontrolled hyperthyroidism or hypothyroidism
4. Severe renal dysfunction
5. Known sensitivity to any of the products to be administered during dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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804 participants in 4 patient groups, including a placebo group

IBI306 450mg SC Q4W

Experimental group

Treatment:

Drug: IBI306 450mg SC Q4W

Placebo SC Q4W

Placebo Comparator group

Treatment:

Drug: Placebo SC Q4W

IBI306 600mg SC Q6W

Experimental group

Treatment:

Drug: IBI306 600mg SC Q6W

Placebo SC Q6W

Placebo Comparator group

Treatment:

Other: Placebo SC Q6W