A Phase Ⅱ Randomized, Parallel-group, Placebo-controlled, Active-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.1 个研究点分布在 1 个国家目标入组 156 人开始时间: 2024年12月3日最近更新: 2026年2月19日

干预措施SYH2053/placebo injection Inclisiran (Leqvio®) 300mg

概览

阶段: 2 期
状态: 已完成
发起方: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
入组人数: 156
试验地点: 1
主要终点: Percentage change in LDL-C relative to baseline

概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

概览

简要总结

The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia.

A total of 156 Participants were actually enrolled

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: Single (Participant)

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

•Age of 18 - 75 years (inclusive);
•Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained a low-fat diet for at least 4 weeks prior to screening. Additionally, meet one of the following criteria:
•A stable dose of lipid-lowering therapy (statin or statin intolerance with other lipid-lowering therapy) ≥4 weeks, or no use of lipid-lowering therapy for ≥4 weeks;
•According to local laboratory results, low-density lipoprotein cholesterol (LDL-C) level ≥100 mg/dL(2.6 mmol/L) and fasting triglycerides ≤400 mg/dL (4.5 mmol/L);
•Participants must understand of the study protocol, including the nature of the intervention and potential adverse events, and must provide voluntary, written informed consent before enrollment;
•Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
•Participants with severe allergic diseases or an allergic constitution (allergies to three or more drugs or foods) or allergic to oligonucleotide drugs；
•History of treatment with PCSK9-targeted antibody therapies or PCSK9-targeted oligonucleotide therapies;
•History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
•Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg during the Screening Period or prior to Randomization (repeat measurement allowed once);

排除标准

未提供