NCT07349615招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 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 hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
- •1.7 ≤ TG ≤ 5.6 mmol/L.
- •LDL-C < 3.4 mmol/L.
- •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.
- •Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
- •Have a history of pancreatitis prior to screening or randomization.
- •Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- •Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- •Malignant tumors within 5 years.
- •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 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.
- •Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- •Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
研究组 & 干预措施
SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；
Experimental
干预措施: SHR-1918/ SHR-1918 placebo (Drug)
SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；
Experimental
干预措施: SHR-1918/ SHR-1918 placebo (Drug)
结局指标
主要结局
Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline
时间窗: at 20 weeks and 24 weeks of treatment
次要结局
- Percentage change in LDL-C 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 LDL-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 and percentage change in Lp(a) relative to baseline(at 24 weeks of treatment)
- Change and percentage change in HDL-C relative to baseline(at 24 weeks of treatment)
- Proportion of subjects with TG < 1.7 mmol/L(at 24 weeks and 48 weeks of treatment)
- Change and percentage change in non-HDL-C relative to baseline(at 48 weeks of treatment)
- Change and percentage change in LDL-C relative to baseline(at 48 weeks of treatment)
- Change and percentage change in TC relative to baseline(at 48 weeks of treatment)
- Change and percentage change in ApoB relative to baseline(at 48 weeks of treatment)
- Change and percentage change in ApoA1 relative to baseline(at 48 weeks of treatment)
- Change and percentage change in Lp(a) relative to baseline(at 48 weeks of treatment)
- Change and percentage change in HDL-C relative to baseline(at 48 weeks of treatment)
- Change and percentage change in TG relative to baseline(at 48 weeks of treatment)
- Proportion of subjects who received rescue treatment(Approximately a year)
- Percentage change in non-HDL-C relative to baseline(at 24 weeks of treatment)
- Percentage change in LDL-C 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 LDL-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 and percentage change in Lp(a) relative to baseline；(at 24 weeks of treatment；)
- Change and percentage change in HDL-C relative to baseline；(at 24 weeks of treatment；)
- Proportion of subjects with TG < 1.7 mmol/L；(at 24 weeks and 48 weeks of treatment；)
- Change and percentage change in non-HDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in LDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in TC relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in ApoB relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in ApoA1 relative to baseline；(at 48 weeks of treatment)
- Change and percentage change in Lp(a) relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in HDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in TG relative to baseline；(at 48 weeks of treatment；)
- Proportion of subjects who received rescue treatment；(Approximately a year；)
- Incidence and severity of adverse events and injection site reactions(Approximately a year)
研究者
研究点 (1)
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