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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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-familiar 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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