Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 7
- 主要终点
- LDL-C change
研究概览
简要总结
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
详细描述
Randomized, Open Label (lipids blinded), Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) at Day 270 of subcutaneous (SC) monthly (QM [≤31 days]) lerodalcibep (LIB003) 300 mg administered to SC inclisiran (Leqvio®) 284 mg at Days 1 and 90 in patients with very-high risk or high-risk CVD or at high risk for CVD with LDL-C ≥85 mg/dL on a stable diet and oral LDL-C-lowering drug therapy
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)
盲法说明
efficacy parameters (lipids) blinded after randomization
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
- •Provision of signed informed consent prior to any study-specific procedure;
- •Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2;
- •Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines
- •High-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other acceptable oral lipid lowering treatment plus diet; stable >4 weeks with LDL-C ≥85 mg/dL and triglycerides ≤400 mg/dL
- •Women of childbearing potential (WOCBP) must continue using a highly effective form of birth control if sexually active
- •Males whose partners are of CBP and not using a highly effective form of birth control will either be surgically sterile or agree to use the following forms of contraception, male or female condom with spermicide
排除标准
- •Prior or active clinical condition or acute and/or unstable systemic disease, including cancer, compromising patient inclusion or preclude completion of the study, at the discretion of the Investigator
- •Homozygous FH
- •non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid
- •PCSK9 mAb within 4 weeks of screening or siRNA within 1 year
- •Severe renal dysfunction, defined eGFR <30 ml/min
- •Recent, within 3 months of screening, atherosclerotic event or intervention
- •planned cardiac procedure
- •NYHA class III or IV heart failure
- •active liver disease
- •uncontrolled diabetes defined as fasting glucose >200 mg/dL and HbA1c > 9%
- •uncontrolled BP ≥180 mmHg systolic or ≥110 mmHg diastolic;
研究组 & 干预措施
lerodalcibep
300 mg SC dosed monthly
干预措施: lerodalcibep (Biological)
inclisiran
284 mg SC dosed Day 1 and Day 90
干预措施: Inclisiran (Drug)
结局指标
主要结局
LDL-C change
时间窗: Day 270
Percent LDL-C change from baseline
次要结局
- Treatment goal achievement(Day 270)
- Apolipoproteins(Day 270)
- Adverse Events(270 days)
- Serum free PCSK9 levels(Day 270)