Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289285
• Other study ID #: CIBI306B301
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2020
• Est. completion date: February 9, 2022

Study information

• Verified date: March 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• IBI306 450mg SC Q4W
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
• Placebo SC Q4W
Subjects will receive placebo every 4 weeks subcutaneously.
• IBI306 600mg SC Q6W
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.

Other:
• Placebo SC Q6W
Subjects will receive placebo every 6 weeks subcutaneously.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48		Week 48
Secondary	The percent of subjects with LDL-C reduction no less than 50% from baseline		Week 48
Secondary	The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)		Week 48
Secondary	The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline		Week 48