NCT03376802已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Sleep energy expenditure
研究概览
简要总结
Primary Objective:
To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.
Secondary Objectives:
- To assess the change in resting, basal and total daily energy expenditure.
- To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.
- To assess the change in body composition and core temperature.
- To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).
- To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.
- To assess the safety and tolerability.
详细描述
Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（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
SAR425899
Experimental
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days
干预措施: SAR425899 (Drug)
Placebo
Placebo Comparator
Repeated once daily SC doses of placebo administered over 19 days
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep energy expenditure
时间窗: Baseline to Day 19
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
次要结局
- Respiratory quotient (RQ)(Baseline to Day 19)
- Ketone bodies(20 days)
- Fat mass and fat-free mass(Baseline to Day 20)
- Adverse events(Up to 27 days)
- Fasting plasma glucose(20 days)
- Basal energy expenditure(Baseline to Day 19)
- Diet Induced Thermogenesis (DIT)(Baseline to Day 19)
- HbA1c(Baseline to Day 20)
- Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)(20 days)
- Pharmacokinetics(Day 16)
- Total daily energy expenditure(Baseline to Day 19)
- Resting energy expenditure(Baseline to Day 19)
研究者
研究点 (2)
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