A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment
研究概览
简要总结
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
- Various parameters of the metabolism and turnover in plasma of different lipoproteins
- Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
- Lipoprotein particle size profile
- PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
详细描述
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo - Alirocumab
Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks
干预措施: alirocumab (Drug)
Placebo - Alirocumab
Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment
时间窗: baseline and at 12 days after last dose of alirocumab
次要结局
- Change in post-heparin hepatic lipase and lipoprotein lipase activities(baseline and at 2 days after last dose of alirocumab)
- Assessment of the serum concentration of anti-alirocumab antibodies(baseline and up to 10 weeks after last dose of alirocumab)
- Assessment of serum concentrations of PCSK9(baseline and up to 2 weeks after last dose of alirocumab)
- Assessment of the serum concentration of alirocumab(baseline and up to 2 weeks after last dose of alirocumab)
- Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)(baseline and at 12 days after last dose of alirocumab)
- Change in lipids and apolipoproteins in plasma lipids panel(baseline and at 2 days and at 11 days after last dose of alirocumab)
- Assessment of Lipoprotein particle size profiles(baseline and at 2 days and at 11 days after last dose of alirocumab)
- Assessment of safety parameters (clinical laboratory, ECG, vital signs)(up to 10 weeks after last dose of alirocumab)