drugset / Trial / NCT03376802

A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects

NCT03376802

Phase 1 Completed 24 enrolled Sanofi
RandomizedParallel-groupTriple-blindBasic science

Summary

Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899. Secondary Objectives: * To assess the change in resting, basal and total daily energy expenditure. * To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation. * To assess the change in body composition and core temperature. * To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c). * To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses. * To assess the safety and tolerability.

Timeline

Start
2018-04-18
Primary completion
2018-12-27
Completion
2018-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR425899 Peptide Subcutaneous