Hypercholesterolemia
Conditions
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
Interventions
DRUGIBI306 450mg SC Q4W
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
DRUGPlacebo SC Q4W
Subjects will receive placebo every 4 weeks subcutaneously.
DRUGIBI306 600mg SC Q6W
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
OTHERPlacebo SC Q6W
Subjects will receive placebo every 6 weeks subcutaneously.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48 | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| The percent of subjects with LDL-C reduction no less than 50% from baseline | Week 48 |
| The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L) | Week 48 |
| The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline | Week 48 |
Countries
China
Outcome results
None listed