A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Percent change of LDL-C
研究概览
简要总结
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin Therapy in Patients with Hypercholesterolemia and Mixed Dyslipidemia.
详细描述
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in Chinese patients with hypercholesterolemia and mixed dyslipidemia at very high or high cardiovascular risk who have not achieved target LDL-C levels despite stable, moderate- to high-intensity statin therapy (with or without ezetimibe).
Approximately 720 participants will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 24 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 28 weeks, with a total study duration of 52 weeks.
The primary efficacy endpoint is the percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24. Key secondary endpoints include the absolute change in LDL-C, the proportion of subjects achieving LDL-C target levels, and changes in other lipid parameters.
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
- •Subjects aged 18 to 75 years.
- •On a stable, moderate- to high-intensity statin regimen (with or without ezetimibe) for at least 4 weeks prior to screening.
- •Fasting LDL-C above target levels per 2023 Chinese guidelines:
- •With ASCVD history: ≥1.4 mmol/L (Extreme Risk) or ≥1.8 mmol/L (Very High Risk). Without ASCVD history: ≥2.6 mmol/L (Moderate/High Risk) or ≥3.4 mmol/L (Low Risk).
- •Fasting triglycerides (TG) ≤ 5.6 mmol/L at screening/randomization.
- •Provide signed informed consent.
排除标准
- •Homozygous Familial Hypercholesterolemia (HoFH).
- •Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
- •Significant cardiovascular event (e.g., MI, unstable angina, stroke, PCI, CABG) within 3 months prior to screening.
- •Heart failure (NYHA Class III or IV) or LVEF <40% within 3 months.
- •Severe renal impairment (eGFR <30 mL/min/1.73m²).
- •Active liver disease or significant hepatic impairment (ALT/AST >2.5x ULN or TBiL >2x ULN).
- •Uncontrolled diabetes (HbA1c >8.0%) or type 1 diabetes.
- •Use of other lipid-lowering therapies (e.g., fibrates, niacin) within 3 months or any PCSK9 inhibitor within 6 months prior to screening.
- •Known hypersensitivity to any component of the investigational product or other antibody therapies.
研究组 & 干预措施
Test Group
SAL003 140 mg
干预措施: SAL003 140 mg (Drug)
Reference Group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change of LDL-C
时间窗: at Week 24
Percent change from baseline in LDL-C at Week 24.
次要结局
未报告次要终点