Hypercholesterolemia
Conditions
Brief summary
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.
Interventions
DRUGIBI306
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
DRUGPlacebo
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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. Uncontrolled hypertension 2. Uncontrolled hyperthyroidism or hypothyroidism 3. Severe renal dysfunction 4. Known sensitivity to any of the products to be administered during dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12 | Baseline to week12 |
Secondary
| Measure | Time frame |
|---|---|
| The percent of subjects with LDL-C reduction no less than 50% from baseline | Baseline to week24 |
| The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L) | Baseline to week24 |
| The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline | Baseline to week24 |
Countries
China
Outcome results
None listed