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

Launched by HOSPICES CIVILS DE LYON · May 31, 2023

Keywords

ClinConnect Summary

The SEMASEARCH trial is studying the effects of a medication called WEGOVY® on individuals struggling with obesity and related health issues. This research will look at both past patients and new patients from 15 specialized obesity centers. The goal is to better understand how WEGOVY® works for different groups of people, especially those with specific conditions like binge eating disorder or obesity caused by medications. Researchers will collect detailed information about the participants and use advanced technology to identify factors that might predict how well someone responds to the treatment.

To be eligible for this study, participants must be at least 18 years old and have a body mass index (BMI) of 40 or higher, along with at least one other weight-related health issue, such as high blood pressure or sleep apnea. Women who are pregnant or breastfeeding cannot participate. Those who join the study can expect to provide information about their health and possibly undergo some medical tests. This trial aims to help create more personalized treatment options for people dealing with obesity.

Gender

ALL

Eligibility criteria

• 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