NCT04844125已完成3 期
A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia
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
- 144
- 试验地点
- 1
- 主要终点
- 12 weeks Percentage change in serum LDL-C levels from baseline.
研究概览
简要总结
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR-1209
Experimental
干预措施: SHR-1209 (Drug)
SHR-1209 Placebo
Placebo Comparator
干预措施: SHR-1209 Placebo (Drug)
结局指标
主要结局
12 weeks Percentage change in serum LDL-C levels from baseline.
时间窗: 12 weeks
次要结局
- 12 weeks Percentage change of non-HDL-C relative to baseline；(12 weeks)
- 12 weeks Absolute Changes in serum LDL-C levels from baseline；(12 weeks)
研究者
研究点 (1)
Loading locations...
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