A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients

Summary

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.

Timeline

Start

2017-12-20

Primary completion

2018-06-07

Completion

2018-06-07

Publications

• Eriksson O, Velikyan I, Haack T, Bossart M, Laitinen I, Larsen PJ, Berglund JE, Antoni G, Johansson L, Pierrou S, Tillner J, Wagner M. Glucagonlike Peptide-1 Receptor Imaging in Individuals with Type 2 Diabetes. J Nucl Med. 2022 May;63(5):794-800. doi: 10.2967/jnumed.121.262506. Epub 2021 Sep 9.

Drugs

Indications