NCT07404553招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
- •TG ≤ 5.6 mmol/L.
- •LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
- •Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.
排除标准
- •History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
- •Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- •Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- •Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
- •Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.
- •History of percutaneous coronary intervention, history of coronary artery bypass grafting (CABG), history of peripheral arterial revascularisation within 1 month prior to screening or randomization.
- •Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- •Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
- •Malignant tumors within 5 years.
- •It's planned to research transcutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery reconstruction, pacemaker implantation, cardiac resynchronisation therapy (CRT), implantable cardioverter defibrillator (ICD) implantation and other implantations during the study.
- •Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
- •Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
- •History of drug use, substance abuse, and alcohol abuse.
- •Participated in or is participating in other clinical studies and has received study interventions within the past month prior to screening.
- •Researchers determine that the subject has poor compliance or any factors that make them unsuitable for participation in this trial, including but not limited to participation in the study placing the subject at unacceptable risk or potentially interfering with the study results.
研究组 & 干预措施
SHR-1918 Injection Group
Experimental
SHR-1918 injection.
干预措施: SHR-1918 Injection (Drug)
SHR-1918 Injection Placebo Group
Placebo Comparator
SHR-1918 injection placebo.
干预措施: SHR-1918 Injection Placebo (Drug)
结局指标
主要结局
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 12 relative to baseline.
时间窗: At 12 weeks of treatment.
Phase 2.
Percentage change in low density lipoprotein cholesterol (LDL-C) levels at Week 24 relative to baseline.
时间窗: At 24 weeks of treatment.
Phase 3.
次要结局
- Percentage change in apolipoprotein B (ApoB) relative to baseline.(At 12 weeks of treatment.)
- Percentage change in Apolipoprotein A1 (ApoA1) relative to baseline.(At 12 weeks of treatment.)
- Change in triglyceride (TG) relative to baseline.(At 12 weeks of treatment.)
- Change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.(At 12 weeks of treatment.)
- Change in total cholesterol (TC) relative to baseline.(At 12 weeks of treatment.)
- Change in apolipoprotein B (ApoB) relative to baseline.(At 12 weeks of treatment.)
- Change in Apolipoprotein A1 (ApoA1) relative to baseline.(AT 12 weeks of treatment.)
- Change in Lipoprotein(a) (Lp(a)) relative to baseline.(At 12 weeks of treatment.)
- Percentage change in Lipoprotein(a) (Lp(a)) relative to baseline.(At 12 weeks of treatment.)
- Change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.(At 12 weeks of treatment.)
- Percentage change in high-density lipoprotein cholesterol (HDL-C) relative to baseline.(At 12 weeks of treatment.)
- Proportion of subjects with the overall LDL-C achievement rate.(At 12 weeks of treatment.)
- Proportion of subjects with the LDL-C achievement rates in different risk groups.(At 12 weeks of treatment.)
- Change in LDL-C decreased by ≥ 50% to baseline.(At 12 weeks of treatment.)
- Percentage change in LDL-C decreased by ≥ 50% to baseline.(At 12 weeks of treatment.)
- Incidence and severity of adverse events (AEs).(Approximately 12 weeks.)
- Incidence and severity of injection site reactions.(Approximately 12 weeks.)
- Percentage change in non-HDL-C relative to baseline.(At 24 weeks of treatment.)
- Percentage change in TG relative to baseline.(At 24 weeks of treatment.)
- Percentage change in TC relative to baseline.(At 24 weeks of treatment.)
- Percentage change in ApoB relative to baseline.(At 24 weeks of treatment.)
- Percentage change in ApoA1 relative to baseline.(At 24 weeks of treatment.)
- Change in TG relative to baseline.(At 24 weeks of treatment.)
- Change in non-HDL-C relative to baseline.(At 24 weeks of treatment.)
- Change in TC relative to baseline.(At 24 weeks of treatment.)
- Change in ApoB relative to baseline.(At 24 weeks of treatment.)
- Change in ApoA1 relative to baseline.(At 24 weeks of treatment.)
- Change in Lp(a) relative to baseline.(At 24 weeks of treatment.)
- Percentage change in Lp(a) relative to baseline.(At 24 weeks of treatment.)
- Change in HDL-C relative to baseline.(At 24 weeks of treatment.)
- Percentage change in HDL-C relative to baseline.(At 24 weeks of treatment.)
- Proportion of subjects with the overall LDL-C achievement rate.(At 24 weeks of treatment.)
- Proportion of subjects with the LDL-C achievement rates in different risk groups.(At 24 weeks of treatment.)
- Change in LDL-C decreased by ≥ 50% to baseline.(At 24 weeks of treatment.)
- Percentage change in LDL-C decreased by ≥ 50% to baseline.(At 24 weeks of treatment.)
- Incidence and severity of adverse events (AEs).(Approximately 24 weeks.)
- Incidence and severity of injection site reactions.(Approximately 24 weeks.)
- Percentage change in non-high-density lipoprotein cholesterol (non-HDL-C) relative to baseline.(At 12 weeks of treatment.)
- Percentage change in triglyceride (TG) relative to baseline.(At 12 weeks of treatment.)
- Percentage change in total cholesterol (TC) relative to baseline.(At 12 weeks of treatment.)
研究者
研究点 (1)
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