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

February 26, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bondy, France, 93140
        • Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier
        • Contact:
      • Colombes, France, 92700
      • Dijon, France, 21000
        • Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy
        • Contact:
      • Dijon, France, 21079
      • La Tronche, France, 38250
        • Service Endocrinologie Diabétologie CHU de Grenoble
        • Contact:
      • Marseille, France, 13385
      • Montpellier, France, 34295
        • Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier
        • Contact:
      • Nantes, France, 44093
        • Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec
        • Contact:
      • Paris, France, 75013
      • Paris, France, 75015
        • Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)
        • Contact:
      • Pessac, France, 33604
      • Poitiers, France, 86021
      • Toulouse, France, 31059
        • Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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®.

Description

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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
New WEGOVY® patients included in the AP2,

At initiation, 6 months and 12 months of WEGOVY® treatment, the following procedures will be performed (in addition to the data collection already provided for in the ATU/AP2):

  • Blood sampling for routine care (max 15mL) and constitution of a plasma bank (28 mL)

  • 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
  • Collection of clinical and biological data from the WEGOVY® ATU/AP eCRF
Other: Data collection
Data collected at initiation, 6 months and 12 months of WEGOVY® treatment will be retrospectively extracted from the WEGOVY® ATU/AP2 eCRF.
Other: Blood sampling
Blood sampling for routine care (max 15mL) and constitution of a plasma bank (28 mL)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weight change between treatment initiation and 12 months after (greater than or equal to 10%)
At initiation of treatment and 12 month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Emmanuel DISSE, Pr, Hospices Civils de Lyon / Service Nutrition Diabétologie Endocrinologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_0954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Data collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe