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

NCT05897398 | Completed

• 1 other identifier: 69HCL22_0954
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Obesity; Bariatric Surgery; Binge Eating Disorder; Syndromic Obesity; Sarcopenic Obesity; Iatrogenic Obesity; Psychotropic Drugs

Keywords

Obesity; Semaglutide; WEGOVY®

Outcome Measures

Primary Outcomes (1)

• Weight trends in patients included in the SEMASEARCH cohort at initiation and 12 months of treatment with WEGOVY®.

  Weight change between treatment initiation and 12 months after (greater than or equal to 10%)

  At initiation of treatment and 12 month of treatment

Secondary Outcomes (23)

• Proportion of responders at Month 12

  12 months

• Change in binge eating and eating behavior

  baseline, 6 and 12 months

• Change in sleep behavior based on Munich ChronoType Questionnaire (MCTQ)

  baseline, 6 and 12 months

• Change in quality of life

  baseline, 6 and 12 months

• Change in physical activity based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF)

  baseline, 6 and 12 months

Other Outcomes (1)

• Exploratory: Identification of clinical, behavioral, and biological predictors of response using interpretable machine learning models

  Through study completion (up to 12 months after treatment initiation)

Study Arms (1)

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.

Other: Data collection; Other: Blood sampling; Other: Questionnaires

Interventions

Data collection OTHER

Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.

Patients already receiving WEGOVY® treatment included in the ATUc/AP2

Blood sampling OTHER

Blood sampling for routine care (max 15mL)

Patients already receiving WEGOVY® treatment included in the ATUc/AP2

Questionnaires OTHER

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

Patients already receiving WEGOVY® treatment included in the ATUc/AP2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients included in the 15 centers in the indication of AP2 : Adults with an initial body mass index ≥ 40 kg/m2 (class III obesity or morbid obesity) in the presence of at least one treated comorbidity (treated hypertension, treated dyslipidemia, treated OSAS, established CVD) and included in the ATUc/AP2 WEGOVY®.

You may qualify if:

• 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
• \*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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (14)

Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier

Bondy, 93140, France

Location

Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier

Colombes, 92700, France

Location

Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy

Dijon, 21000, France

Location

Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon

Dijon, 21079, France

Location

Service Endocrinologie Diabétologie CHU de Grenoble

La Tronche, 38250, France

Location

Service Endocrinologie Hôpital Conception - APHM

Marseille, 13385, France

Location

Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier

Montpellier, 34295, France

Location

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

Nantes, 44093, France

Location

Service Nutrition APHP - GHU Pitié Salpêtrière

Paris, 75013, France

Location

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

Paris, 75015, France

Location

Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux

Pessac, 33604, France

Location

Service Endocrinologie Diabétologie Nutrition CHU Poitiers

Poitiers, 86021, France

Location

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

Toulouse, 31059, France

Location

Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Obesity; Binge-Eating Disorder

Interventions

Data Collection; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Emmanuel DISSE, Pr

  Hospices Civils de Lyon / Service Nutrition Diabétologie Endocrinologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 10, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (14)