A Study of IBI306 in Participants With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709536
• Other study ID #: CIBI306B201
• Status: Recruiting
• Phase: Phase 3
• Start date: February 9, 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Yang Yu
• Phone: 0512-69566088
• Email: yang.yu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• 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. Uncontrolled hypertension

2. Uncontrolled hyperthyroidism or hypothyroidism

3. Severe renal dysfunction

4. Known sensitivity to any of the products to be administered during dosing

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• IBI306
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
• Placebo
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

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	1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12		Baseline to week12
Secondary	The percent of subjects with LDL-C reduction no less than 50% from baseline		Baseline to week24
Secondary	The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)		Baseline to week24
Secondary	The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline		Baseline to week24