drugset / Trial / NCT03376802
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAR425899 | Peptide | — | Subcutaneous |