Status:
COMPLETED
A Study of IBI306 in Participants With Hypercholesterolemia
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 hypercholesterolemi...
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
- 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 :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04709536
Start Date
February 9 2021
End Date
January 28 2022
Last Update
October 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, China