NCT04164888已完成2 期
A Placebo-controlled, Randomized, Phase 2a, Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CIVI 007 in Patients on a Background of Stable Statin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Assessment of the Pharmacodynamic Effect of CIVI 007
研究概览
简要总结
Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 18.0 and 40.0
- •Stable (>4 weeks prior to the Screening Visit) dose of statin therapy with or without ezetimibe
- •Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.
- •Fasting triglycerides (TGs) <400 mg/dL
排除标准
- •Women who are pregnant, nursing or breast feeding
- •Currently prescribed a lipid lowering agent other than a statin or ezetimibe.
- •Clinically significant disorder or laboratory abnormality that could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
研究组 & 干预措施
CIVI 007, Dose A
Experimental
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
干预措施: CIVI 007 (Drug)
CIVI 007, Dose B
Experimental
SC injection of PCSK9 inhibitor- dose titration
干预措施: CIVI 007 (Drug)
CIVI 007, Dose C
Experimental
SC injection of PCSK9 inhibitor- high dose given twice
干预措施: CIVI 007 (Drug)
Placebo
Placebo Comparator
Placebo SC injection matching PCSK9 inhibitor given twice
干预措施: CIVI 007 (Drug)
结局指标
主要结局
Assessment of the Pharmacodynamic Effect of CIVI 007
时间窗: Baseline, D29, D57, D85
Percent change from baseline in PCSK9
次要结局
- Assessment of the Lipid Efficacy of CIVI 007(Baseline, Day 29, Day 57, Day 85)
- Assessment of CIVI 007 Adverse Events (AEs)(Baseline through 2 month follow-up)
研究者
研究点 (1)
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