Clinical trial NCT04849000: Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage
Official title: Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of SHR-1209 Monotherapy in Patients With Primary Hypercholesterolemia and Mixed Hyperlipemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Mixed Hyperlipemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1209 monotherapy
Primary purpose: TREATMENT

Brief summary: The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
2. Fasting LDL-C was ≥2.6mmol/L and \<4.9mmol/L at screening and randomization；
3. Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.

Exclusion Criteria:

1. 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;
2. 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);
3. 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.
4. 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.

Primary outcomes:
measure: 12-weeks or 16weeks Percentage change in LDL-C relative to baseline
timeFrame: 12-weeks or 16weeks
Secondary outcomes:
measure: 12-weeks or 16weeks change in LDL-C relative to baseline；
timeFrame: 12-weeks or 16weeks
measure: Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment
timeFrame: 12 weeks or 16 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangzhou
Study officials:
References: