NCT03549260已完成2 期
Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
LIB Therapeutics LLC10 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年5月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 10
- 主要终点
- Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
研究概览
简要总结
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
详细描述
Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on 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
Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial
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 or female, 18 years of age or older
- •Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
- •Body mass index (BMI) between 18 and 40 kg/m2
排除标准
- •Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
- •Homozygous familial hypercholesterolemia
- •LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
- •Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- •Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- •Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes
- •Uncontrolled hypertension
- •Moderate to severe renal insufficiency
- •Elevated liver function test at screening
- •Uncontrolled cardiac arrhythmia or prolonged QT on EKG
- •A history of prescription drug abuse, illicit drug use, or alcohol abuse
研究组 & 干预措施
LIB003 350 mg or matching placebo
Experimental
SC LIB003 350 mg or placebo every 4 weeks
干预措施: LIB003 (Biological)
LIB003 300 mg or matching placebo
Experimental
SC LIB003 300 mg or placebo every 4 weeks
干预措施: LIB003 (Biological)
LIB003 150 mg or matching placebo
Experimental
SC LIB003 150 mg or placebo every 4 weeks
干预措施: LIB003 (Biological)
结局指标
主要结局
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
时间窗: baseline to 12 weeks
Change in serum LDL-C from baseline after 12 weeks
次要结局
- Percent reduction in apolipoprotein B (Apo B) at week 12(baseline to 12 weeks)
- Percent reduction in lipoprotein (a) [Lp(a)] at week 12(baseline to 12 weeks)
- Percent reduction in free PCSK9 at week 12(baseline to 12 weeks)
- Presence of anti LIB003 antibodies (ADAs)(baseline to 12 weeks)
- The incidence and severity of treatment emergent adverse events (TEAEs)(baseline to 12 weeks)
研究者
研究点 (10)
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