NCT04849000已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 1
- 主要终点
- 12-weeks or 16weeks Percentage change in LDL-C relative to baseline
研究概览
简要总结
The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR-1209 Placebo
Placebo Comparator
干预措施: SHR-1209 Placebo (Drug)
SHR-1209
Experimental
干预措施: SHR-1209 (Drug)
结局指标
主要结局
12-weeks or 16weeks Percentage change in LDL-C relative to baseline
时间窗: 12-weeks or 16weeks
次要结局
- 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(12 weeks or 16 weeks)
- 12-weeks or 16weeks change in LDL-C relative to baseline；(12-weeks or 16weeks)
研究者
研究点 (1)
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