Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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.
Study duration is approximately 7 weeks with a 20 days treatment period. ;
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