NCT03350191

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study duration is approximately 7 weeks with a 20 days treatment period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR425899	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	[68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer)	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	[68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2017-12-20
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-11-22
• Last updated: 2022-04-25

Locations

1 site across 1 country: Sweden