Overview

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

Status:
Completed

Trial end date:
2018-06-07

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Sanofi

Collaborator:

Antaros Medical

Treatments:

Exenatide
Glucagon
Glucagon-Like Peptide 1