Phase
Condition
Weight Loss
Bulimia
Drugs
Treatment
Questionnaires
Data collection
Blood sampling
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Inclusion Criteria Male or female
Aged over 18 years
Patient included in the WEGOVY® ATU/AP program in one of the 14 participating CSOs: initial Body Mass Index (BMI) ≥ 40 kg/m² (Class III or morbid obesity) and presence of at least one weight-related comorbidity: treated hypertension, treated dyslipidemia, established cardiovascular disease, treated sleep apnea syndrome; and in the absence of therapeutic alternatives
Patient has been informed and has not objected to participation in the study
Patient affiliated with a French social security scheme
- Tagging Criteria to Identify Subpopulations of Interest (for classification purposes only - not a condition for inclusion)
*1 Patients with a history of bariatric surgery:
At least 1 year post-bariatric surgery (definitive technique or gastric band still in place)
Defined as failure if:
Initial %EWL < 50% (even without weight regain) and/or weight regain > 20% of lost weight compared to postoperative nadir
*2 Patients with Binge Eating Disorder (BED):
Defined by the clinician according to DSM-5 criteria for BED:
a. Recurrent episodes of binge eating, characterized by both: Eating, in a discrete period of time, an amount of food that is definitely larger than what most individuals would eat in a similar time under similar circumstances A sense of lack of control over eating during the episode
b. The binge eating episodes are associated with three (or more) of the following: Eating much more rapidly than normal Eating until uncomfortably full Eating large amounts of food when not physically hungry Eating alone due to embarrassment Feeling disgusted with oneself, depressed or guilty afterward
c. Marked distress regarding binge eating
d. The binge eating occurs, on average, at least once a week for 5 months
e. The behavior is not associated with regular inappropriate compensatory behavior (e.g., purging, fasting, excessive exercise) and does not occur exclusively during anorexia nervosa or bulimia nervosa
*3 Patients with rare monogenic or syndromic obesity: According to the French national guidelines (PNDS) for rare obesity causes: HAS website
- Includes:
Hypothalamic (lesional) obesity, such as craniopharyngioma Genetic forms of obesity
- Most frequently encountered syndromes:
Prader-Willi syndrome Bardet-Biedl syndrome 16p11.2 deletion or SH2B1 variant LEPR, POMC, PCSK1, and MC4R variants
- 4 Older patients:
- Age > 60 years
- 5 Patients with extreme obesity:
a. BMI ≥ 60 kg/m²
*6 Patients with obesity under psychotropic treatment:
Presence of one or more of the following treatments at baseline:
i. Antidepressants: Agomelatine, Amitriptyline, Citalopram, Clomipramine, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Imipramine, Iproniazid, Mianserin, Milnacipran, Mirtazapine, Moclobemide, Paroxetine, Sertraline, Tianeptine, Venlafaxine, Vortioxetine
ii. Antipsychotics: Amisulpride, Aripiprazole, Chlorpromazine, Clozapine, Cyamemazine, Flupenthixol, Fluphenazine, Haloperidol, Levomepromazine, Loxapine, Olanzapine, Pimozide, Pipamperone, Prochlorperazine, Quetiapine, Risperidone/Paliperidone, Sulpiride, Tiapride, Zuclopenthixol
iii. Mood stabilizers: Lithium carbonate, Carbamazepine, Lamotrigine, Oxcarbazepine, Sodium divalproate, Valpromide
iv. Psychostimulants: Methylphenidate
v. Anxiolytics: Antihistamines, anticonvulsants, or other anxiolytic agents
*7 Non-specific patients: Patients not meeting any of the above subpopulation criteria
- Exclusion Criteria
Pregnant or breastfeeding women
Persons under legal protection or guardianship
- Criteria for Early Study Withdrawal
Early withdrawal from the study will occur in the following cases:
The patient withdraws their non-opposition to participation
The patient discontinues treatment with WEGOVY® prematurely
Study Design
Connect with a study center
Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier
Bondy, 93140
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier
Bondy 3031815, 93140
FranceSite Not Available
Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier
Colombes, 92700
FranceSite Not Available
Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier
Colombes 3024266, 92700
FranceSite Not Available
Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy
Dijon, 21000
FranceSite Not Available
Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon
Dijon, 21079
FranceSite Not Available
Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy
Dijon 3021372, 21000
FranceSite Not Available
Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon
Dijon 3021372, 21079
FranceSite Not Available
Service Endocrinologie Diabétologie CHU de Grenoble
La Tronche, 38250
FranceSite Not Available
Service Endocrinologie Diabétologie CHU de Grenoble
La Tronche 3006131, 38250
FranceSite Not Available
Service Endocrinologie Hôpital Conception - APHM
Marseille, 13385
FranceSite Not Available
Service Endocrinologie Hôpital Conception - APHM
Marseille 2995469, 13385
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier
Montpellier, 34295
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier
Montpellier 2992166, 34295
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec
Nantes, 44093
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec
Nantes 2990969, 44093
FranceSite Not Available
Service Nutrition APHP - GHU Pitié Salpêtrière
Paris, 75013
FranceSite Not Available
Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)
Paris, 75015
FranceSite Not Available
Service Nutrition APHP - GHU Pitié Salpêtrière
Paris 2988507, 75013
FranceSite Not Available
Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)
Paris 2988507, 75015
FranceSite Not Available
Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux
Pessac, 33604
FranceSite Not Available
Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux
Pessac 2987805, 33604
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition CHU Poitiers
Poitiers, 86021
FranceSite Not Available
Service Endocrinologie Diabétologie Nutrition CHU Poitiers
Poitiers 2986495, 86021
FranceSite Not Available
Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)
Toulouse, 31059
FranceSite Not Available
Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)
Toulouse 2972315, 31059
FranceSite Not Available
Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy
Vandœuvre-lès-Nancy, 54500
FranceSite Not Available
Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy
Vandœuvre-lès-Nancy 2970797, 54500
FranceSite Not Available
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