NCT03376802

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

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR425899	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2018-04-18
• Primary completion: 2018-12-27
• Completion: 2018-12-27
• First posted: 2017-12-19
• Last updated: 2022-04-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study