Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
1 other identifier
interventional
804
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedApril 11, 2022
March 1, 2022
1.8 years
February 26, 2020
April 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
Week 48
Secondary Outcomes (3)
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
Study Arms (4)
IBI306 450mg SC Q4W
EXPERIMENTALPlacebo SC Q4W
PLACEBO COMPARATORIBI306 600mg SC Q6W
EXPERIMENTALPlacebo SC Q6W
PLACEBO COMPARATORInterventions
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
April 29, 2020
Primary Completion
February 9, 2022
Study Completion
February 9, 2022
Last Updated
April 11, 2022
Record last verified: 2022-03