First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

Summary

Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)

Timeline

Start

2019-04-25

Primary completion

2019-09-26

Completion

2019-09-26

Publications

• Bossart M, Wagner M, Elvert R, Evers A, Hubschle T, Kloeckener T, Lorenz K, Moessinger C, Eriksson O, Velikyan I, Pierrou S, Johansson L, Dietert G, Dietz-Baum Y, Kissner T, Nowotny I, Einig C, Jan C, Rharbaoui F, Gassenhuber J, Prochnow HP, Agueusop I, Porksen N, Smith WB, Nitsche A, Konkar A. Effects on weight loss and glycemic control with SAR441255, a potent unimolecular peptide GLP-1/GIP/GCG receptor triagonist. Cell Metab. 2022 Jan 4;34(1):59-74.e10. doi: 10.1016/j.cmet.2021.12.005. Epub 2021 Dec 20.

Drugs

Indications