Back to resultsSHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1209
SHR-1209 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Any male or female aged between 18 and 80 on the date of signing the informed consent;
- Diagnosed as hypercholesterolemia ;
- Fasting triglyceride was less than 5.6 mmol/L during screening:
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion Criteria:
A history of the following diseases or treatments during the screening period:
- Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
- Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
Any of the laboratory test indicators meets the following criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
- The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
Have used the following drugs:
- PCSK9 inhibitors had been used in the previous 6 months;
- Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
Other circumstances:
- Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
- Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SHR-1209
SHR-1209 Placebo
Arm Description
Outcomes
Primary Outcome Measures
12 weeks Percentage change in serum LDL-C levels from baseline.
Secondary Outcome Measures
12 weeks Absolute Changes in serum LDL-C levels from baseline；
12 weeks Percentage change of non-HDL-C relative to baseline；
Full Information
NCT ID
NCT04844125
First Posted
April 2, 2021
Last Updated
April 24, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04844125
Brief Title
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
Official Title
A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)
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
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Background Lipolowering therapy in combination with SHR-1209/ placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR-1209
Arm Type
Experimental
Arm Title
SHR-1209 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1209
Intervention Description
SHR-1209
Intervention Type
Drug
Intervention Name(s)
SHR-1209 Placebo
Intervention Description
SHR-1209 Placebo
Primary Outcome Measure Information:
Title
12 weeks Percentage change in serum LDL-C levels from baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
12 weeks Absolute Changes in serum LDL-C levels from baseline；
Time Frame
12 weeks
Title
12 weeks Percentage change of non-HDL-C relative to baseline；
Time Frame
12 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:
Any male or female aged between 18 and 80 on the date of signing the informed consent;
Diagnosed as hypercholesterolemia ;
Fasting triglyceride was less than 5.6 mmol/L during screening:
Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion Criteria:
A history of the following diseases or treatments during the screening period:
Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
Any of the laboratory test indicators meets the following criteria:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
Have used the following drugs:
PCSK9 inhibitors had been used in the previous 6 months;
Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
Other circumstances:
Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
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