search
Back to results

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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IBI306 450mg SC Q4W
Placebo SC Q4W
IBI306 600mg SC Q6W
Placebo SC Q6W
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

IBI306 450mg SC Q4W

Placebo SC Q4W

IBI306 600mg SC Q6W

Placebo SC Q6W

Arm Description

Outcomes

Primary Outcome Measures

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48

Secondary Outcome Measures

The percent of subjects with LDL-C reduction no less than 50% from baseline
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline

Full Information

First Posted
February 26, 2020
Last Updated
April 2, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04289285
Brief Title
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI306 450mg SC Q4W
Arm Type
Experimental
Arm Title
Placebo SC Q4W
Arm Type
Placebo Comparator
Arm Title
IBI306 600mg SC Q6W
Arm Type
Experimental
Arm Title
Placebo SC Q6W
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IBI306 450mg SC Q4W
Intervention Description
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo SC Q4W
Intervention Description
Subjects will receive placebo every 4 weeks subcutaneously.
Intervention Type
Drug
Intervention Name(s)
IBI306 600mg SC Q6W
Intervention Description
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
Intervention Type
Other
Intervention Name(s)
Placebo SC Q6W
Intervention Description
Subjects will receive placebo every 6 weeks subcutaneously.
Primary Outcome Measure Information:
Title
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
The percent of subjects with LDL-C reduction no less than 50% from baseline
Time Frame
Week 48
Title
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Time Frame
Week 48
Title
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs