SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®

Last updated: August 29, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Completed

Phase

N/A

Condition

Weight Loss

Bulimia

Drugs

Treatment

Questionnaires

Data collection

Blood sampling

Clinical Study ID

NCT05897398
69HCL22_0954
  • Ages 18-99
  • All Genders

Study Summary

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.

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:

  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

  1. 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:
  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

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

Total Participants: 1100
Treatment Group(s): 3
Primary Treatment: Questionnaires
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
June 10, 2025

Connect with a study center

  • Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier

    Bondy, 93140
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier

    Bondy 3031815, 93140
    France

    Site Not Available

  • Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier

    Colombes, 92700
    France

    Site Not Available

  • Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier

    Colombes 3024266, 92700
    France

    Site Not Available

  • Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy

    Dijon, 21000
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon

    Dijon, 21079
    France

    Site Not Available

  • Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy

    Dijon 3021372, 21000
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon

    Dijon 3021372, 21079
    France

    Site Not Available

  • Service Endocrinologie Diabétologie CHU de Grenoble

    La Tronche, 38250
    France

    Site Not Available

  • Service Endocrinologie Diabétologie CHU de Grenoble

    La Tronche 3006131, 38250
    France

    Site Not Available

  • Service Endocrinologie Hôpital Conception - APHM

    Marseille, 13385
    France

    Site Not Available

  • Service Endocrinologie Hôpital Conception - APHM

    Marseille 2995469, 13385
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec

    Nantes, 44093
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec

    Nantes 2990969, 44093
    France

    Site Not Available

  • Service Nutrition APHP - GHU Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)

    Paris, 75015
    France

    Site Not Available

  • Service Nutrition APHP - GHU Pitié Salpêtrière

    Paris 2988507, 75013
    France

    Site Not Available

  • Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)

    Paris 2988507, 75015
    France

    Site Not Available

  • Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux

    Pessac, 33604
    France

    Site Not Available

  • Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux

    Pessac 2987805, 33604
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition CHU Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • Service Endocrinologie Diabétologie Nutrition CHU Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)

    Toulouse, 31059
    France

    Site Not Available

  • Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy

    Vandœuvre-lès-Nancy 2970797, 54500
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.