Status:
COMPLETED
Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Primary Hypercholesterolemia
Mixed Hyperlipemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
Eligibility Criteria
Inclusion
- Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
- Fasting LDL-C was ≥2.6mmol/L and \<4.9mmol/L at screening and randomization；
- Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.
Exclusion
- 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 cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;
- Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
709 Patients enrolled
Trial Details
Trial ID
NCT04849000
Start Date
April 23 2021
End Date
January 13 2023
Last Update
May 19 2023
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China, 510120