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ObesitySEMASEARCHNCT05897398

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

An observational study of Obesity and Bariatric Surgery, run by Hospices Civils de Lyon at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Bariatric Surgery, Binge Eating Disorder
What is being tested?
Data collection, Blood sampling and Questionnaires
How many people
1,100 participants
Where
14 sitesFrance
Study dates
10 Jun 2024to 10 Jun 2025
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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®.

Who may be able to join

  • 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:
Show all 41Show fewer
  • 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:
  • 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
  • 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
  • Marked distress regarding binge eating
  • The binge eating occurs, on average, at least once a week for 5 months
  • 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:
  • BMI ≥ 60 kg/m²
  • 6 Patients with obesity under psychotropic treatment:
  • Presence of one or more of the following treatments at baseline:
  • Antidepressants: Agomelatine, Amitriptyline, Citalopram, Clomipramine, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Imipramine, Iproniazid, Mianserin, Milnacipran, Mirtazapine, Moclobemide, Paroxetine, Sertraline, Tianeptine, Venlafaxine, Vortioxetine
  • Antipsychotics: Amisulpride, Aripiprazole, Chlorpromazine, Clozapine, Cyamemazine, Flupenthixol, Fluphenazine, Haloperidol, Levomepromazine, Loxapine, Olanzapine, Pimozide, Pipamperone, Prochlorperazine, Quetiapine, Risperidone/Paliperidone, Sulpiride, Tiapride, Zuclopenthixol
  • Mood stabilizers: Lithium carbonate, Carbamazepine, Lamotrigine, Oxcarbazepine, Sodium divalproate, Valpromide
  • Psychostimulants: Methylphenidate
  • 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

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier

    Bondy, 93140

  • Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier

    Colombes, 92700

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

    Dijon, 21000

  • Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon

    Dijon, 21079

  • Service Endocrinologie Diabétologie CHU de Grenoble

    La Tronche, 38250

  • Service Endocrinologie Hôpital Conception - APHM

    Marseille, 13385

  • Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier

    Montpellier, 34295

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

    Nantes, 44093

  • Service Nutrition APHP - GHU Pitié Salpêtrière

    Paris, 75013

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

    Paris, 75015

  • Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux

    Pessac, 33604

  • Service Endocrinologie Diabétologie Nutrition CHU Poitiers

    Poitiers, 86021

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

    Toulouse, 31059

  • Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

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.

Being tested
Data collection, Blood sampling, Questionnaires
Keywords
Obesity, Semaglutide, WEGOVY®
Medical subject headings
Obesity, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

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

  • Blood samplingOther

    Blood sampling for routine care (max 15mL)

  • QuestionnairesOther

    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

Study groups in NCT05897398
Study groupRoleWhat they receive
Patients already receiving WEGOVY® treatment included in the ATUc/AP2Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
Receives: Other: Data collection; Other: Blood sampling; Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%)

    Measured: At initiation of treatment and 12 month of treatment

Secondary outcomes (23)

  1. Proportion of responders at Month 12

    Defined as an absolute weight loss ≥10% from baseline to 12 months after treatment initiation

    Measured: 12 months

  2. Change in binge eating and eating behavior

    Change in binge eating and eating behavior based on Binge Eating Scale (BES)

    BES (Binge Eating Scale): 16-item self-report questionnaire, total score ranges from 0 to 46. Higher scores indicate more severe binge eating symptoms.

    Measured: baseline, 6 and 12 months

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

    Munich ChronoType Questionnaire (MCTQ) assesses sleep duration and chronotype using 6 questions. Derived variables include average sleep duration and midpoint of sleep. Higher sleep duration values reflect longer average sleep; midpoint values indicate chronotype.

    Measured: baseline, 6 and 12 months

  4. Change in quality of life

    EQ-5D-5L measures 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 5 levels. Results include:

    Index value: ranges from <0 (worse than death) to 1 (perfect health).

    Visual Analog Scale (VAS): 0-100, higher scores = better perceived health.

    Measured: baseline, 6 and 12 months

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

    The short version of the IPAQ (International Physical Activity Questionnaire) assesses overall physical activity and sedentary behavior over the past seven days. The questionnaire focuses on vigorous and moderate physical activity, walking, and time spent sitting (sedentary behavior), whether during leisure activities, work, daily life, or transportation. This short form includes 7 questions that can be self-administered or answered, for example, over the phone. The questionnaire categorizes individuals into three levels of activity: low, moderate, or high.

    Measured: baseline, 6 and 12 months

  6. Change in gastrointestinal symptoms based on the reduced Gastrointestinal Quality of Life Index (GIQLI)

    Reduced GIQLI has 13 items, each scored from 0 to 4. Total score ranges from 0 to 52. Higher scores indicate better gastrointestinal quality of life.

    Measured: baseline, 6 and 12 months

  7. Change in anxiety and depression based on Hospital Anxiety and Depression Scale (HADS)

    HADS has 14 items (7 for anxiety, 7 for depression). Each item is scored 0-3; subscale scores range from 0 to 21. Higher scores indicate more severe symptoms.

    Measured: baseline, 6 and 12 months

  8. Evolution of metabolic comorbidities - Change in fasting glucose level (mg/dL)

    Fasting plasma glucose will be collected from clinical records at each time point. Values are expressed in milligrams per deciliter (mg/dL). A decrease in glucose level reflects an improvement in glycemic control.

    Measured: baseline, 6 and 12 months

  9. Number of participants with treatment-related adverse events reported in the eCRF at 6 and 12 months

    All adverse events recorded in the electronic Case Report Form (eCRF) will be reported, classified by type, severity, and relationship to treatment.

    Measured: 6 and 12 months

  10. Change in body composition - Change in fat mass percentage measured by Dual-Energy X-ray Absorptiometry (DXA)

    Body fat percentage will be measured using DXA (dual-energy X-ray absorptiometry). Values are expressed as a percentage (%) of total body mass. A lower fat mass percentage over time is considered a positive outcome reflecting improved body composition.

    Measured: baseline, 6 and 12 months

  11. Change in muscle strength based on chair stand test

    Chair Stand Test: number of stands in 30 seconds.

    Measured: baseline, 6 and 12 months

  12. Difference in lean mass between sarcopenic and non-sarcopenic patients

    Lean body mass will be measured using Dual-Energy X-ray Absorptiometry (DXA) and/or Bioelectrical Impedance Analysis (BIA). Values will be expressed in kilograms (kg) and/or as a percentage of total body mass (%). The outcome will compare mean values between participants classified as sarcopenic and those classified as non-sarcopenic at each time point. Higher lean mass indicates better muscle preservation.

    Measured: baseline, 6 and 12 months

  13. Change in body weight in each subpopulation

    Body weight change from baseline to 6 and 12 months in subgroups of interest (e.g. BED, extreme obesity, sarcopenia, psychotropics)

    Measured: baseline, 6 and 12 months

  14. Proportion of responders by subpopulation at Month 12

    Proportion of patients achieving ≥10% weight loss at 12 months in each subpopulation

    Measured: baseline and 12 months

  15. Change in binge eating disorder symptoms in binge eating disorder subgroup

    Change in binge eating disorder symptoms according to medical routine monitoring.

    Measured: baseline and 12 months

  16. Change in prevalence of extreme obesity

    Percentage of patients with BMI ≥60 kg/m^2 at baseline and at 12 months in extreme obesity subgroup

    Measured: baseline and 12 months

  17. Change in psychotropic medication use at 12 months in patients on psychotropic medication

    Proportion of patients who reduced, maintained, or increased psychotropic medication use.

    Measured: baseline and 12 months

  18. Evolution of metabolic comorbidities - Change in liver enzymes (ALT and AST - U/L)

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels will be assessed as indicators of liver function. Values will be expressed in units per liter (U/L). Lower levels over time may reflect improved hepatic function or reduced liver inflammation.

    Measured: Baseline, 6 months, and 12 months

  19. Evolution of metabolic comorbidities - Change in lipid profile (total cholesterol, HDL, LDL, triglycerides - mg/dL)

    Lipid parameters will be collected from routine blood tests

    Measured: Baseline, 6 months, and 12 months

  20. Change in body composition - Change in lean body mass measured by Bioelectrical Impedance Analysis (BIA)

    Lean body mass will be assessed using bioelectrical impedance analysis (BIA). Results are expressed in kilograms (kg). An increase in lean mass over time indicates improved muscular composition and overall body health.

    Measured: Baseline, 6 months, and 12 months

  21. Difference in muscle strength between sarcopenic and non-sarcopenic patients

    Muscle strength will be assessed using Chair stand test measuring the number of repetitions in 30 seconds.

    Measured: Baseline, 6 months, and 12 months

  22. Change in eating behavior based on Dutch Eating Behavior Questionnaire (DEBQ)

    DEBQ is a 34-item questionnaire assessing emotional eating, external eating, and cognitive restraint. Higher scores indicate more disordered eating patterns.

    Measured: Baseline, 6 months, 12 months

  23. Change in hunger based on Hunger Score

    Hunger Score consists of 4 items scored from 0 to 10. Higher score reflects greater hunger.

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start10 Jun 2024
  3. Primary completion10 Jun 2025
  4. Study completion10 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,100 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897398
Sponsor's protocol ID
69HCL22_0954
Acronym
SEMASEARCH
Status last verified
Aug 2025
First submitted
31 May 2023
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Guo J, Hayes MR, Leggio L, Oru E, Rinaman L. GLP-1 Receptor Agonists and Research to Treat Overeating and Substance Use Disorders. J Neurosci. 2025 Nov 12;45(46):e1375252025. doi: 10.1523/JNEUROSCI.1375-25.2025.

    PubMed 41224657

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Bariatric Surgery, run by Hospices Civils de Lyon at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight trends in patients included in the SEMASEARCH cohort at initiation and 12 months of treatment with WEGOVY®. (time frame: At initiation of treatment and 12 month of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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