Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380426
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-11
Brief Title:
Real-life Evaluation of WEGOVY Semaglutide Treatment in Adults With Monogenic Obesity ObGeSema
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Multicenter Pharmacoepidemiological Cohort on Real Life Use of WEGOVY Semaglutide in Obese Patients With Monogenic Obesity
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:
ObGeSema
Brief Summary:
Rare genetic forms of obesity so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways
More than 60 genes encoding for proteins located in the hypothalamic leptinmelanocortin pathway have been described in the French National Protocol for Diagnostic and Care PNDS
The natural history of monogenic obesity is characterized by an early onset in childhood with a major increase in weight in adolescence and young adulthood The worsening of obesity exposes these patients to severe complications
Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers Clinical management is complex and requires comprehensive specialized and multidisciplinary management But the usual lifestyle approaches have so far shown disappointing results similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity justifying new approaches
In this context evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications
GLP-1 glucagon-like peptide 1 based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications This is the case for Semaglutide 24mgweek WEGOVY developed by Novo Nordisk However there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity
The hypothesis in this study is that treatment with Semaglutide 24mgweek WEGOVY could be as effective in monogenic obesities as in common obesity
More than 60 genes encoding for proteins located in the hypothalamic leptinmelanocortin pathway have been described in the French National Protocol for Diagnostic and Care PNDS
The natural history of monogenic obesity is characterized by an early onset in childhood with a major increase in weight in adolescence and young adulthood The worsening of obesity exposes these patients to severe complications
Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers Clinical management is complex and requires comprehensive specialized and multidisciplinary management But the usual lifestyle approaches have so far shown disappointing results similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity justifying new approaches
In this context evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications
GLP-1 glucagon-like peptide 1 based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications This is the case for Semaglutide 24mgweek WEGOVY developed by Novo Nordisk However there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity
The hypothesis in this study is that treatment with Semaglutide 24mgweek WEGOVY could be as effective in monogenic obesities as in common obesity
Detailed Description:
Rare genetic forms of obesity so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways More than 60 genes encoding for proteins located in the hypothalamic leptinmelanocortin pathway have been described in the French National Protocol for Diagnostic and Care PNDS
The natural history of monogenic obesity is characterized by an early onset in childhood with a major increase in weight in adolescence and young adulthood The worsening of obesity exposes these patients to severe complications Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers Clinical management is complex and requires comprehensive specialized and multidisciplinary management But the usual lifestyle approaches have so far shown disappointing results similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity justifying new approaches
In this context evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications
GLP-1 glucagon-like peptide 1 based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications This is the case for Semaglutide 24mgweek WEGOVY developed by Novo Nordisk However there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity
The hypothesis in this study is that treatment with Semaglutide 24mgweek WEGOVY could be as effective in monogenic obesities as in common obesity
This study is a multicenter study which involves French largest Specialized Obesity Centers CSO among which the APHP coordinating center All adult patients with a genetic diagnosis of obesity to whom Wegovy is proposed as part of the WEGOVY early access andor commercialization or for whom Wegovy has already been initiated will be proposed to participate to the study This also includes any patient having initiated the treatment and already having interrupted it for any reason
After the information has been done the patient or guardian gives to the physician their oral non-opposition for the study that is recorded in the medical records
This study will take advantage of WEGOVYs pre-marketing early access authorisation andor commercialization in France to set up a longitudinal follow-up of patients with monogenic obesity receiving Semaglutide
Patients already treated with semaglutide at the time of study start ie patients having initiated the treatment in the Early Access programme will be included and followed-up whereas inclusion and prospective follow-up of newly treated patients will only begin when Semaglutide becomes officially available
The aim of the ObGeSema project is to set up a cohort composed of patients 1 having already initiated a treatment and 2 newly treated by Semaglutide in 14 Specialized Obesity Centres CSOs and describe their evolution over a 4 year follow-up
The natural history of monogenic obesity is characterized by an early onset in childhood with a major increase in weight in adolescence and young adulthood The worsening of obesity exposes these patients to severe complications Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers Clinical management is complex and requires comprehensive specialized and multidisciplinary management But the usual lifestyle approaches have so far shown disappointing results similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity justifying new approaches
In this context evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications
GLP-1 glucagon-like peptide 1 based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications This is the case for Semaglutide 24mgweek WEGOVY developed by Novo Nordisk However there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity
The hypothesis in this study is that treatment with Semaglutide 24mgweek WEGOVY could be as effective in monogenic obesities as in common obesity
This study is a multicenter study which involves French largest Specialized Obesity Centers CSO among which the APHP coordinating center All adult patients with a genetic diagnosis of obesity to whom Wegovy is proposed as part of the WEGOVY early access andor commercialization or for whom Wegovy has already been initiated will be proposed to participate to the study This also includes any patient having initiated the treatment and already having interrupted it for any reason
After the information has been done the patient or guardian gives to the physician their oral non-opposition for the study that is recorded in the medical records
This study will take advantage of WEGOVYs pre-marketing early access authorisation andor commercialization in France to set up a longitudinal follow-up of patients with monogenic obesity receiving Semaglutide
Patients already treated with semaglutide at the time of study start ie patients having initiated the treatment in the Early Access programme will be included and followed-up whereas inclusion and prospective follow-up of newly treated patients will only begin when Semaglutide becomes officially available
The aim of the ObGeSema project is to set up a cohort composed of patients 1 having already initiated a treatment and 2 newly treated by Semaglutide in 14 Specialized Obesity Centres CSOs and describe their evolution over a 4 year follow-up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2023-A02003-42 | OTHER | ANSM | None |