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A Study of IBI306 in Participants With Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IBI306
Placebo
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. Uncontrolled hypertension
  2. Uncontrolled hyperthyroidism or hypothyroidism
  3. Severe renal dysfunction
  4. Known sensitivity to any of the products to be administered during dosing

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IBI306

Placebo

Arm Description

IBI306 administered subcutaneously (SC)

administered subcutaneously (SC)

Outcomes

Primary Outcome Measures

1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12

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
January 12, 2021
Last Updated
April 29, 2021
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04709536
Brief Title
A Study of IBI306 in Participants With Hypercholesterolemia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

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
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.

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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI306
Arm Type
Experimental
Arm Description
IBI306 administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
administered subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
IBI306
Intervention Description
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
Primary Outcome Measure Information:
Title
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
Time Frame
Baseline to week12
Secondary Outcome Measure Information:
Title
The percent of subjects with LDL-C reduction no less than 50% from baseline
Time Frame
Baseline to week24
Title
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Time Frame
Baseline to week24
Title
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Time Frame
Baseline to week24

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 Uncontrolled hypertension Uncontrolled hyperthyroidism or hypothyroidism Severe renal dysfunction Known sensitivity to any of the products to be administered during dosing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yu
Phone
0512-69566088
Email
yang.yu@innoventbio.com
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Huo

12. IPD Sharing Statement

Learn more about this trial

A Study of IBI306 in Participants With Hypercholesterolemia

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