Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia and Hyperlipidemia
Primary Purpose
Hypercholesterolemia, Hyperlipidemia
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1209 ;placebo
SHR-1209 ;placebo
SHR-1209 ;placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
- The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion Criteria:
- Have the following diseases or treatment history :(1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening ;
- Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
- General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
- The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
Sites / Locations
- Beijing Anzhen Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1:SHR-1209 / placebo
Cohort 2:SHR-1209 /placebo
Cohort 3:SHR-1209 / placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage change in LDL-C relative to baseline
Secondary Outcome Measures
The value of changes in LDL-C relative to baseline
blood pressure with the unit of mm Hg
body temperature with the unit of °C
pulse rate with the unit of beats per minute
Breathe with the unit of beats per minunt
adverse events
injection reactions, the investigators through check up the skin of abdomen
Full Information
NCT ID
NCT04885218
First Posted
April 30, 2021
Last Updated
May 23, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04885218
Brief Title
Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia and Hyperlipidemia
Official Title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in the Stable Treatment of Patients With Hypercholesterolemia and Hyperlipidemia .
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with hypercholesterolemia and hyperlipidemia after lipid-lowering therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR-1209 combined with lipid-lowering agents
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
692 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1:SHR-1209 / placebo
Arm Type
Experimental
Arm Title
Cohort 2:SHR-1209 /placebo
Arm Type
Experimental
Arm Title
Cohort 3:SHR-1209 / placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1209 ;placebo
Intervention Description
SHR-1209/placebo high dose
Intervention Type
Drug
Intervention Name(s)
SHR-1209 ;placebo
Intervention Description
SHR-1209/placebo medium dose
Intervention Type
Drug
Intervention Name(s)
SHR-1209 ;placebo
Intervention Description
SHR-1209/placebo low dose
Primary Outcome Measure Information:
Title
Percentage change in LDL-C relative to baseline
Time Frame
at 24 weeks of treatment.
Secondary Outcome Measure Information:
Title
The value of changes in LDL-C relative to baseline
Time Frame
at 24 weeks of treatment.
Title
blood pressure with the unit of mm Hg
Time Frame
through study completion, an average of 56 weeks
Title
body temperature with the unit of °C
Time Frame
through study completion, an average of 56 weeks
Title
pulse rate with the unit of beats per minute
Time Frame
through study completion, an average of 56 weeks
Title
Breathe with the unit of beats per minunt
Time Frame
through study completion, an average of 56 weeks
Title
adverse events
Time Frame
through study completion, an average of 56 weeks
Title
injection reactions, the investigators through check up the skin of abdomen
Time Frame
through study completion, an average of 56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion Criteria:
Have the following diseases or treatment history :(1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening ;
Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia and Hyperlipidemia
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