NCT06471218已完成2 期
Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年7月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Percent change in calculated LDL-C from baseline to week 24
研究概览
简要总结
Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
- •Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
- •TG≤5.6mmol/L.
排除标准
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
- •Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
- •Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
- •Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
- •Glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).
研究组 & 干预措施
Treatment A:SHR-1918/SHR-1918 Placebo
Experimental
干预措施: SHR-1918; SHR-1918 Placebo (Drug)
Treatment B:SHR-1918/SHR-1918 Placebo
Experimental
干预措施: SHR-1918; SHR-1918 Placebo (Drug)
结局指标
主要结局
Percent change in calculated LDL-C from baseline to week 24
时间窗: from baseline to week 24
次要结局
- Percent change in calculated TG from baseline to week 24(from baseline to week 24)
研究者
研究点 (1)
Loading locations...
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