Status:
COMPLETED
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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)...
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 o...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Males and females ≥ 18 to ≤ 75 years of age
- Diagnosis of hypercholesterolemia
- LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
- Very high or high cardiovascular risk
- TG≤500 mg/dL(5.64 mmol/L)
- Exclusion criteria:
- Diagnosis of HoFH or HeFH
- Uncontrolled hypertension
- Uncontrolled hyperthyroidism or hypothyroidism
- Severe renal dysfunction
- Known sensitivity to any of the products to be administered during dosing
Exclusion
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT04289285
Start Date
April 29 2020
End Date
February 9 2022
Last Update
April 11 2022
Active Locations (1)
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1
Peking University First Hospital
Beijing, China