A PET/CT Study to Assess the Receptor Occupancy by SAR425899 After Repeat Dosing Using Radiolabelled Tracers for the Glucagon and GLP-1 Receptor in Overweight to Obese T2DM Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Glucagon receptor occupancy
研究概览
简要总结
Primary Objectives:
To assess in overweight to obese T2DM patients:
- The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a tracer compound.
- The GLP-1 receptor occupancy of SAR425899 at two dose levels in the human pancreas with PET imaging using [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 as a tracer compound.
- Pharmacodynamic effects on fasting plasma glucose and biomarkers of lipid metabolism.
- Pharmacokinetic parameters for SAR425899 after repeated subcutaneous (SC) doses in plasma.
- Safety and tolerability of SAR425899.
详细描述
Study duration is approximately 7 weeks with a 20 days treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR425899 high dose
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days
干预措施: SAR425899 (Drug)
SAR425899 high dose
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days
干预措施: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) (Drug)
SAR425899 high dose
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days
干预措施: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) (Drug)
SAR425899 low dose
Repeated once daily SC doses of SAR425899 administered over 20 days
干预措施: SAR425899 (Drug)
SAR425899 low dose
Repeated once daily SC doses of SAR425899 administered over 20 days
干预措施: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) (Drug)
SAR425899 low dose
Repeated once daily SC doses of SAR425899 administered over 20 days
干预措施: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) (Drug)
结局指标
主要结局
Glucagon receptor occupancy
时间窗: Day 1 and Day 20
Change of glucagon receptor tracer binding in the liver with SAR425899 between Day 1 and Day 20
次要结局
- Pharmacokinetics(Day 20)
- Change in ketone bodies(Day 1 to Day 20)
- Change lipid biomarkers(Day 1 to Day 20)
- GLP-1 receptor occupancy(Day 1 and Day 17)
- Change in volume of distribution (Vt) in the liver(Day 1 and Day 20)
- Adverse events(Up to 27 days)
- Change in fasting plasma glucose (FPG)(Day 1 to Day 20)
- Change in Vt in the pancreas(Day 1 and Day 17)
- Average standard uptake values (SUVs) of PET tracers in the liver and pancreas(Day 1, Day 17 and Day 20)