NCT07640217尚未招募2 期
A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).
详细描述
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥18 years of age;
- •Elevated Lp(a);
- •Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;
- •Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
- •Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.
排除标准
- •Diseases that significantly affect Lp(a) during screening period,
- •Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
- •Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;
- •NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
- •Type 1 diabetes or hereditary hemorrhagic disorder at screening;
- •History of malignant tumor or suspected malignancy within 5 years prior to screening;
- •Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
- •Allergy to oligonucleotide drugs;
- •Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
- •Female participants who are pregnant or breastfeeding at screening, or female / male participants who plan to conceive during the study and within 1 year after the last dose.
研究者
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