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

Completed

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

• Registration Number: NCT05897398
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2024-06-10
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight trends in patients included in the SEMASEARCH cohort at initiation and 12 months of treatment with WEGOVY®.	At initiation of treatment and 12 month of treatment	Weight change between treatment initiation and 12 months after (greater than or equal to 10%)

Secondary Outcome Measures

Name	Time	Method
Proportion of responders at Month 12	12 months	Defined as an absolute weight loss ≥10% from baseline to 12 months after treatment initiation
Change in binge eating and eating behavior	baseline, 6 and 12 months	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.
Change in sleep behavior based on Munich ChronoType Questionnaire (MCTQ)	baseline, 6 and 12 months	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.
Change in quality of life	baseline, 6 and 12 months	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.
Change in physical activity based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF)	baseline, 6 and 12 months	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.
Change in gastrointestinal symptoms based on the reduced Gastrointestinal Quality of Life Index (GIQLI)	baseline, 6 and 12 months	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.
Change in anxiety and depression based on Hospital Anxiety and Depression Scale (HADS)	baseline, 6 and 12 months	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.
Evolution of metabolic comorbidities - Change in fasting glucose level (mg/dL)	baseline, 6 and 12 months	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.
Number of participants with treatment-related adverse events reported in the eCRF at 6 and 12 months	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.
Change in body composition - Change in fat mass percentage measured by Dual-Energy X-ray Absorptiometry (DXA)	baseline, 6 and 12 months	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.
Change in muscle strength based on chair stand test	baseline, 6 and 12 months	Chair Stand Test: number of stands in 30 seconds.
Difference in lean mass between sarcopenic and non-sarcopenic patients	baseline, 6 and 12 months	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.
Change in body weight in each subpopulation	baseline, 6 and 12 months	Body weight change from baseline to 6 and 12 months in subgroups of interest (e.g. BED, extreme obesity, sarcopenia, psychotropics)
Proportion of responders by subpopulation at Month 12	baseline and 12 months	Proportion of patients achieving ≥10% weight loss at 12 months in each subpopulation
Change in binge eating disorder symptoms in binge eating disorder subgroup	baseline and 12 months	Change in binge eating disorder symptoms according to medical routine monitoring.
Change in prevalence of extreme obesity	baseline and 12 months	Percentage of patients with BMI ≥60 kg/m\^2 at baseline and at 12 months in extreme obesity subgroup
Change in psychotropic medication use at 12 months in patients on psychotropic medication	baseline and 12 months	Proportion of patients who reduced, maintained, or increased psychotropic medication use.
Evolution of metabolic comorbidities - Change in liver enzymes (ALT and AST - U/L)	Baseline, 6 months, and 12 months	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.
Evolution of metabolic comorbidities - Change in lipid profile (total cholesterol, HDL, LDL, triglycerides - mg/dL)	Baseline, 6 months, and 12 months	Lipid parameters will be collected from routine blood tests
Change in body composition - Change in lean body mass measured by Bioelectrical Impedance Analysis (BIA)	Baseline, 6 months, and 12 months	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.
Difference in muscle strength between sarcopenic and non-sarcopenic patients	Baseline, 6 months, and 12 months	Muscle strength will be assessed using Chair stand test measuring the number of repetitions in 30 seconds.
Change in eating behavior based on Dutch Eating Behavior Questionnaire (DEBQ)	Baseline, 6 months, 12 months	DEBQ is a 34-item questionnaire assessing emotional eating, external eating, and cognitive restraint. Higher scores indicate more disordered eating patterns.
Change in hunger based on Hunger Score	Baseline, 6 months, 12 months	Hunger Score consists of 4 items scored from 0 to 10. Higher score reflects greater hunger.

Trial Locations

Locations (14)

Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier; 🇫🇷 Bondy, France

Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier; 🇫🇷 Colombes, France

Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy; 🇫🇷 Dijon, France

Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon; 🇫🇷 Dijon, France

Service Endocrinologie Diabétologie CHU de Grenoble; 🇫🇷 La Tronche, France

Service Endocrinologie Hôpital Conception - APHM; 🇫🇷 Marseille, France

Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier; 🇫🇷 Montpellier, France

Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec; 🇫🇷 Nantes, France

Service Nutrition APHP - GHU Pitié Salpêtrière; 🇫🇷 Paris, France

Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP); 🇫🇷 Paris, France

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