Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426446
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-13
Brief Title:
Monitoring Patients With Severe Obesity Treated With Wegovy Using Connected Device Real-world Data
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Monitoring Patients With Severe Obesity Treated With Wegovy Using Connected Device Real-world Data
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
TELE-SEMA
Brief Summary:
This study involves collecting real-world data on body weight body composition cardiovascular parameters and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy
Detailed Description:
Obesity is a chronic disease associated with numerous co-morbidities New treatments for obesity notably GLP-1 Glucagon-like peptide 1 analogs have led to promising advances Semaglutide 24 mg weekly subcutaneous injection marketed under the brand name Wegovy was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c However few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy
The TELE-SEMA project involves collecting real-world data on body weight body composition cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy
The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss body composition and possible eating disorders
The TELE-SEMA project involves collecting real-world data on body weight body composition cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy
The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss body composition and possible eating disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None