Informations générales (source: ClinicalTrials.gov)
SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®
Observational [Patient Registry]
Hospices Civils de Lyon (Voir sur ClinicalTrials)
avril 2024
avril 2026
15 septembre 2025
The aim of the SEMASEARCH project is therefore to constitute a retrospective cohort, from
the available data on patients already included in the ATUc/AP2, and prospective, on new
patients who will initiate treatment according to the AP2 PUT, of 15 Specialized Obesity
Centers in order to describe the effect of WEGOVY® treatment in this population. Thanks
to a high phenotyping, subpopulations of interest will be identified to know the
specifics of the effect of the treatment in these subgroups of interest. Secondary
analyses will aim to look for clinical or biological biomarkers of success in the weight
response to WEGOVY® in the entire prospective cohort, but also in specific
subpopulations.
In summary, the analysis of the entire SEMASEARCH cohort and sub-populations of interest
will be based on a complete clinical phenotyping of patients (included in retrospective
and prospective studies), completed by ad hoc questionnaires and associated with
biological markers (prospective) partly collected within the framework of the WEGOVY® AP
(glycaemia, hepatic assessment, lipid assessment ) and partly from a biobank to test
specific hypotheses (predictive role of leptin sensitivity, insulin sensitivity level,
plasma level of endocannabinoids, etc.).
In addition, approaches using artificial intelligence (AI), notably machine learning,
will make it possible to determine the variables or combination of variables that are
most predictive of the weight response to treatment with WEGOVY® in the largest
population. Indeed, individual weight loss in response to weight loss strategies is
highly variable, whether purely related to lifestyle changes or pharmacological.
Well-known factors associated with the ability to lose weight include adherence to
lifestyle change, gender, age and specific medications. However, after controlling for
these factors, differences in weight loss appear to persist in response to different
interventions including pharmacological ones. Adaptation to energy deficit involves
complex feedback mechanisms, and inter-individual differences are likely to arise from a
range of poorly defined factors. Thus, a better understanding of the factors involved in
inter-individual variability in response to WEGOVY® will help guide more personalised
approaches to the management of these patients. AI techniques will be used to determine
which combination of clinical or biological variables are most predictive of weight
response.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | CARETTE Claire, Pr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Jean Verdier | Mohamed ZERGUINE, Dr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Louis Mourier | Séverine LEDOUX, Dr | Contact (sur clinicalTrials) | |||
| GHU PARIS PSY ET NEUROSCIENCES | Christine POITOU, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy - 21000 - Dijon - France | Cyril GAUTHIER, Dr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy - 54500 - Vandœuvre-lès-Nancy - France | Didier QUILLIOT, Dr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabétologie CHU de Grenoble - 38250 - La Tronche - France | Anne-Laure BOREL, Pr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon - 21079 - Dijon - France | Marie-Claude BRINDISI, Pr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec - 44093 - Nantes - France | David JACOBI, Pr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabétologie Nutrition CHU Poitiers - 86021 - Poitiers - France | Helena MOSBAH, Dr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier - 34295 - Montpellier - France | Antoine AVIGNON, Pr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Hôpital Conception - APHM - 13385 - Marseille - France | Bénédicte GABORIT, Dr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux - 33604 - Pessac - France | Blandine GATTA-CHERIFI, Dr | Contact (sur clinicalTrials) | |||
| Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse) - 31059 - Toulouse - France | Emilie MONTASTIER, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Over 18 years of age
- Initial body mass index (BMI) ≥ 40 kg/m² (class III obesity or morbid obesity) in
the presence of at least one weight related comorbidity factor:
- Treated hypertension
- Treated dyslipidemia
- Established cardiovascular disease
- Treated Sleep apnea syndrome
- Patient enrolled in ATUc/AP2 WEGOVY®SEMAGLUTIDE 2.4mg/wk in the 15 participating CSO
- Patient who was informed and did not object to participate in the study
- Patient enrolled in a social security scheme
- Pregnant or lactating women are excluded from the WEGOVY® ATUc/AP2. Effective
contraception is required for women of childbearing potential to access WEGOVY® AP.
- Criteria for tagging, at baseline, patients according to the following subpopulation
of interest: (the tag does not condition the inclusion of the patient in this
cohort, it makes it possible to identify the subpopulations):
Patients with a history of bariatric surgery:
- 1 year or more after bariatric surgery (definitive technique or ring in place)
- Surgery failure defined by: i-Initial PEP < 50% (including no weight gain) // ii-
and/or weight regain > 20% of the weight lost compared to the postoperative weight
nadir
Patients with severe eating disorder, binge eating disorder : To be defined by the
clinician according to the DSM5 definition of binge eating disorder
- Recurrent occurrence of binge eating, hyperphagic attack meeting the following two
characteristics: i- Absorption, in a limited period of time, of a much greater
amount of food than most people would absorb in a similar period of time and under
the same circumstances // ii- Feeling of loss of control over eating behaviour
during binge eating:
- Binge eating is associated with three (or more) of the following characteristics:i-
Eat much faster than normal. ii- Eat until you experience a painful feeling of
abdominal distension.// Iii- Eating large amounts of food in the absence of a
physical feeling of hunger.// Iv- Eating alone because you are embarrassed about the
amount of food you absorb.// V- Feeling disgusted with yourself, depressed or very
guilty after eating.
- Bulimic behavior is a source of marked suffering. d- Bulimic behavior occurs, on
average, at least 1 day a week for 5 months.
- Bulimic behaviour is not associated with the regular use of inappropriate
compensatory behaviours (e.g., vomiting or purgative, fasting, excessive physical
exercise) and does not occur during anorexia nervosa or bulimia.
Patients with a rare form of monogenic or syndromic obesity OR psychomotor retardation
All the situations described in the PNDS Obesity of rare causes:
https://www.hassante.fr/jcms/p_3280217/fr/generique-obesites-de-causes-rares
- These are: i- hypothalamic lesional obesity such as craniopharyngiomas // ii-
obesity of genetic origin.
- The most frequently encountered are: i-Prader-Willi // ii-BardetBiedl // iii
Délétion16p11.2ouvariantSH2B1 // iv- Variants LEPR, POMC,PCSK1 et MC4R The list of
genes is detailed in the link:
https://docs.google.com/spreadsheets/d/1vQUcZna_vjpgVLLtylDKc1zIVRNvoSPOVlTsixUdT
Wg/edit# gid=0.
Sarcopenic elderly patients:
- Age > 60
- Pathological chair lift test (gets up 5 times from a chair without standing in + 15
seconds)
Patients with extreme obesity:
- IMC>60kg/m²
Patients with iatrogenic obesity induced by psychotropic drugs:
- Presence of one of the following treatments at the patient's baseline: i-
Antidepressants:1- selective serotonin reuptake inhibitors (SSRIs) / 2-Serotonin
reuptake inhibitors and norepinephrine (the "double-action") / 3-tricyclic
antidepressants (TCAs) / 4-"other antidepressants" : a- Thymoregulatory drugs:
Lithium, Valproate, Gabapentine, Carbamazépine, Lamotrigine, Topiramate OR b-
Antipsychotics (i- Typical (= first generation): chlorpromazine, levomépromazine,
cyamémazine, halopéridol, dropéridol, sulpiride, amisulpride // ii- Atypical (=
second generation): zuclopenthixol, clozapine, cloxapine, olanzapine, risperidone,
quetiapine)
Non-specific patient (patient who does not have a criterion that can be classified into
one of the subpopulations)
Patient NOT tagged (Tag not done or insufficient elements to classify the patient)
- Over 18 years of age
- Initial body mass index (BMI) ≥ 40 kg/m² (class III obesity or morbid obesity) in
the presence of at least one weight related comorbidity factor:
- Treated hypertension
- Treated dyslipidemia
- Established cardiovascular disease
- Treated Sleep apnea syndrome
- Patient enrolled in ATUc/AP2 WEGOVY®SEMAGLUTIDE 2.4mg/wk in the 15 participating CSO
- Patient who was informed and did not object to participate in the study
- Patient enrolled in a social security scheme
- Pregnant or lactating women are excluded from the WEGOVY® ATUc/AP2. Effective
contraception is required for women of childbearing potential to access WEGOVY® AP.
- Criteria for tagging, at baseline, patients according to the following subpopulation
of interest: (the tag does not condition the inclusion of the patient in this
cohort, it makes it possible to identify the subpopulations):
Patients with a history of bariatric surgery:
- 1 year or more after bariatric surgery (definitive technique or ring in place)
- Surgery failure defined by: i-Initial PEP < 50% (including no weight gain) // ii-
and/or weight regain > 20% of the weight lost compared to the postoperative weight
nadir
Patients with severe eating disorder, binge eating disorder : To be defined by the
clinician according to the DSM5 definition of binge eating disorder
- Recurrent occurrence of binge eating, hyperphagic attack meeting the following two
characteristics: i- Absorption, in a limited period of time, of a much greater
amount of food than most people would absorb in a similar period of time and under
the same circumstances // ii- Feeling of loss of control over eating behaviour
during binge eating:
- Binge eating is associated with three (or more) of the following characteristics:i-
Eat much faster than normal. ii- Eat until you experience a painful feeling of
abdominal distension.// Iii- Eating large amounts of food in the absence of a
physical feeling of hunger.// Iv- Eating alone because you are embarrassed about the
amount of food you absorb.// V- Feeling disgusted with yourself, depressed or very
guilty after eating.
- Bulimic behavior is a source of marked suffering. d- Bulimic behavior occurs, on
average, at least 1 day a week for 5 months.
- Bulimic behaviour is not associated with the regular use of inappropriate
compensatory behaviours (e.g., vomiting or purgative, fasting, excessive physical
exercise) and does not occur during anorexia nervosa or bulimia.
Patients with a rare form of monogenic or syndromic obesity OR psychomotor retardation
All the situations described in the PNDS Obesity of rare causes:
https://www.hassante.fr/jcms/p_3280217/fr/generique-obesites-de-causes-rares
- These are: i- hypothalamic lesional obesity such as craniopharyngiomas // ii-
obesity of genetic origin.
- The most frequently encountered are: i-Prader-Willi // ii-BardetBiedl // iii
Délétion16p11.2ouvariantSH2B1 // iv- Variants LEPR, POMC,PCSK1 et MC4R The list of
genes is detailed in the link:
https://docs.google.com/spreadsheets/d/1vQUcZna_vjpgVLLtylDKc1zIVRNvoSPOVlTsixUdT
Wg/edit# gid=0.
Sarcopenic elderly patients:
- Age > 60
- Pathological chair lift test (gets up 5 times from a chair without standing in + 15
seconds)
Patients with extreme obesity:
- IMC>60kg/m²
Patients with iatrogenic obesity induced by psychotropic drugs:
- Presence of one of the following treatments at the patient's baseline: i-
Antidepressants:1- selective serotonin reuptake inhibitors (SSRIs) / 2-Serotonin
reuptake inhibitors and norepinephrine (the "double-action") / 3-tricyclic
antidepressants (TCAs) / 4-"other antidepressants" : a- Thymoregulatory drugs:
Lithium, Valproate, Gabapentine, Carbamazépine, Lamotrigine, Topiramate OR b-
Antipsychotics (i- Typical (= first generation): chlorpromazine, levomépromazine,
cyamémazine, halopéridol, dropéridol, sulpiride, amisulpride // ii- Atypical (=
second generation): zuclopenthixol, clozapine, cloxapine, olanzapine, risperidone,
quetiapine)
Non-specific patient (patient who does not have a criterion that can be classified into
one of the subpopulations)
Patient NOT tagged (Tag not done or insufficient elements to classify the patient)
- Criteria for non-inclusion in the WEGOVY® ATUc/AP2
- Vulnerable patient (person under guardianship or curatorship, or deprived of liberty
by a judicial or administrative decision).
- Pregnant women or breastfeeding