Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT03376802
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1191-5658 | OTHER | UTN | View |