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

NCT03350191 · Completed

Last updated 2026-05-28

This study is testing whether a drug called SAR425899 attaches to the liver and pancreas in adults who have type 2 diabetes and are overweight or obese.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) basic-science study

Participants 13 people

Who can join Ages 18–75 · all sexes

Timeline Started 2017-12 · est. completion 2018-06

Where 1 site · Sweden

What this study is testing ClinicalTrials.gov NCT03350191 ↗

Description as written by the study sponsor.

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.

Treatments tested

SAR425899 Drug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
[68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) Drug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
[68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) Drug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Main thing measured	Glucagon receptor occupancy
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03350191 ↗