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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04289285
Collaborator
(none)
804
Enrollment
1
Location
4
Arms
21.4
Actual Duration (Months)
37.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: IBI306 450mg SC Q4W
  • Drug: Placebo SC Q4W
  • Drug: IBI306 600mg SC Q6W
  • Other: Placebo SC Q6W
 Phase 3

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
804 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 29, 2020
Actual Primary Completion Date :
Feb 9, 2022
Actual Study Completion Date :
Feb 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: IBI306 450mg SC Q4W

Drug: IBI306 450mg SC Q4W
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
Placebo Comparator: Placebo SC Q4W

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

Drug: IBI306 600mg SC Q6W
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
Placebo Comparator: Placebo SC Q6W

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

Outcome Measures

Primary Outcome Measures

  1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48 [Week 48]

Secondary Outcome Measures

  1. The percent of subjects with LDL-C reduction no less than 50% from baseline [Week 48]

  2. The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L) [Week 48]

  3. The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline [Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University First Hospital Beijing China

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04289285
Other Study ID Numbers:
  • CIBI306B301
First Posted:
Feb 28, 2020
Last Update Posted:
Apr 11, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypercholesterolemia

Study Results

No Results Posted as of Apr 11, 2022