SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®
NCT ID: NCT05897398
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1100 participants
OBSERVATIONAL
2024-06-10
2025-06-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients already receiving WEGOVY® treatment included in the ATUc/AP2
Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
Data collection
Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
Blood sampling
Blood sampling for routine care (max 15mL)
Questionnaires
Completion of questionnaires for the entire cohort:
To assess hyperphagia and eating behaviour: BES, DEBQ and Hunger Score questionnaire To assess physical activity: short IPAQ To assess sleep behaviour: MCTQ To assess quality of life: EQ5D5L To assess digestive system disorders: GIQLI To assess anxiety and depression: HAD
Interventions
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Data collection
Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
Blood sampling
Blood sampling for routine care (max 15mL)
Questionnaires
Completion of questionnaires for the entire cohort:
To assess hyperphagia and eating behaviour: BES, DEBQ and Hunger Score questionnaire To assess physical activity: short IPAQ To assess sleep behaviour: MCTQ To assess quality of life: EQ5D5L To assess digestive system disorders: GIQLI To assess anxiety and depression: HAD
Eligibility Criteria
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Inclusion Criteria
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:
1. At least 1 year post-bariatric surgery (definitive technique or gastric band still in place)
2. 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
1. Includes:
Hypothalamic (lesional) obesity, such as craniopharyngioma Genetic forms of obesity
2. 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:
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1. 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
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
18 Years
99 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Emmanuel DISSE, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon / Service Nutrition Diabétologie Endocrinologie
Locations
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Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier
Bondy, , France
Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier
Colombes, , France
Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy
Dijon, , France
Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon
Dijon, , France
Service Endocrinologie Diabétologie CHU de Grenoble
La Tronche, , France
Service Endocrinologie Hôpital Conception - APHM
Marseille, , France
Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier
Montpellier, , France
Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec
Nantes, , France
Service Nutrition APHP - GHU Pitié Salpêtrière
Paris, , France
Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)
Paris, , France
Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux
Pessac, , France
Service Endocrinologie Diabétologie Nutrition CHU Poitiers
Poitiers, , France
Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)
Toulouse, , France
Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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69HCL22_0954
Identifier Type: -
Identifier Source: org_study_id
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