NCT04885218已完成3 期
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 Non-familial Hypercholesterolemia and Mixed Hyperlipidemia .
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
- 692
- 试验地点
- 1
- 主要终点
- Percentage change in LDL-C relative to baseline
研究概览
简要总结
To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy
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;
- •The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
- •Fasting triglycerides less than equal to 5.6 mmol/L；
- •Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
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 familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.
- •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.
研究组 & 干预措施
Cohort 1：SHR-1209 / placebo
Experimental
干预措施: SHR-1209 ;placebo (Drug)
Cohort 2：SHR-1209 /placebo
Experimental
干预措施: SHR-1209 ;placebo (Drug)
Cohort 3：SHR-1209 / placebo
Experimental
干预措施: SHR-1209 ;placebo (Drug)
结局指标
主要结局
Percentage change in LDL-C relative to baseline
时间窗: at 24 weeks of treatment
次要结局
- Percentage change in LP (a) relative to baseline,(at 48 weeks of treatment;)
- Percentage change in LDL-C relative to baseline(at 48 weeks of treatment;)
- Percentage change in TC/HDL-C relative to baseline,(at 48 weeks of treatment)
- Percentage change in non-HDL-C relative to baseline(at 48 weeks of treatment;)
- Percentage change in TC/HDL-C relative to baseline(at 24 weeks of treatment;)
- The value of change in LDL-C relative to baseline ,(at 48 weeks of treatment;)
- Percentage change in ApoB relative to baseline(at 48 weeks of treatment;)
- Percentage change in ApoB/ApoA1 relative to baseline,(at 48 weeks of treatment;)
- Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,(at 48 weeks of treatment.)
- The value of change in LDL-C relative to baseline(at 24 weeks of treatment)
- Percentage change in TG relative to baseline(at 48 weeks of treatment;)
研究者
研究点 (1)
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