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SEMASEARCH
CompletedSEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
14
Recruiting sites
—
Enrollment
1,100
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥40•Established CVD
Primary endpoint
•≥10% weight-loss responders
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
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®.
Eligibility criteria
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:
1. At least 1 year post-bariatric surgery (definitive technique or gastric band still in place)
2. 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
*3 Patients with rare monogenic or syndromic obesity: According to the French national guidelines (PNDS) for rare obesity causes: HAS website
1. Includes:
Hypothalamic (lesional) obesity, such as craniopharyngioma Genetic forms of obesity
2. Most frequently encountered syndromes:
Prader-Willi syndrome Bardet-Biedl syndrome 16p11.2 deletion or SH2B1 variant LEPR, POMC, PCSK1, and MC4R variants
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1. Age > 60 years
a. BMI ≥ 60 kg/m²
*6 Patients with obesity under psychotropic treatment:
Presence of one or more of the following treatments at baseline:
i. Antidepressants: Agomelatine, Amitriptyline, Citalopram, Clomipramine, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Imipramine, Iproniazid, Mianserin, Milnacipran, Mirtazapine, Moclobemide, Paroxetine, Sertraline, Tianeptine, Venlafaxine, Vortioxetine
ii. Antipsychotics: Amisulpride, Aripiprazole, Chlorpromazine, Clozapine, Cyamemazine, Flupenthixol, Fluphenazine, Haloperidol, Levomepromazine, Loxapine, Olanzapine, Pimozide, Pipamperone, Prochlorperazine, Quetiapine, Risperidone/Paliperidone, Sulpiride, Tiapride, Zuclopenthixol
iii. Mood stabilizers: Lithium carbonate, Carbamazepine, Lamotrigine, Oxcarbazepine, Sodium divalproate, Valpromide
iv. Psychostimulants: Methylphenidate
v. 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
Endpoints (25)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
9 endpointsWeight 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
≥10% weight-loss responders
threshold achievement, improvement
Proportion of responders at Month 12
Time frame:12 months
≥10% weight-loss responders
threshold achievement, improvement
Change in body composition - Change in fat mass percentage measured by Dual-Energy X-ray Absorptiometry (DXA)
Time frame:baseline, 6 and 12 months
Total fat mass
change from baseline, improvement
Difference in lean mass between sarcopenic and non-sarcopenic patients
Time frame:baseline, 6 and 12 months
Lean mass
descriptive, improvement
Change in body weight in each subpopulation
Time frame:baseline, 6 and 12 months
Body weight, absolute change (kg)
change from baseline, improvement
Proportion of responders by subpopulation at Month 12
Time frame:baseline and 12 months
≥10% weight-loss responders
threshold achievement, improvement
Change in prevalence of extreme obesity
Time frame:baseline and 12 months
threshold achievement, improvement
Change in body composition - Change in lean body mass measured by Bioelectrical Impedance Analysis (BIA)
Time frame:Baseline, 6 months, and 12 months
Lean mass
change from baseline, improvement
Difference in muscle strength between sarcopenic and non-sarcopenic patients
Time frame:Baseline, 6 months, and 12 months
descriptive
Glycemic / diabetes
1 endpointEvolution of metabolic comorbidities - Change in fasting glucose level (mg/dL)
Time frame:baseline, 6 and 12 months
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
MASH / liver
1 endpointEvolution of metabolic comorbidities - Change in liver enzymes (ALT and AST - U/L)
Time frame:Baseline, 6 months, and 12 months
ALT, change
change from baseline, improvement
LOINC 1742-6
Cardiometabolic biomarkers
1 endpointEvolution of metabolic comorbidities - Change in lipid profile (total cholesterol, HDL, LDL, triglycerides - mg/dL)
Time frame:Baseline, 6 months, and 12 months
change from baseline, improvement
Patient-reported / QoL
6 endpointsChange in binge eating and eating behavior
Time frame:baseline, 6 and 12 months
change from baseline, improvement
Change in quality of life
Time frame:baseline, 6 and 12 months
EQ-5D index
change from baseline, improvement
Change in gastrointestinal symptoms based on the reduced Gastrointestinal Quality of Life Index (GIQLI)
Time frame:baseline, 6 and 12 months
change from baseline, improvement
Change in anxiety and depression based on Hospital Anxiety and Depression Scale (HADS)
Time frame:baseline, 6 and 12 months
change from baseline, improvement
Change in eating behavior based on Dutch Eating Behavior Questionnaire (DEBQ)
Time frame:Baseline, 6 months, 12 months
change from baseline, improvement
Change in hunger based on Hunger Score
Time frame:Baseline, 6 months, 12 months
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of participants with treatment-related adverse events reported in the eCRF at 6 and 12 months
Time frame:6 and 12 months
Treatment-emergent AEs (any)
event count, event
Other clinical outcomes
5 endpointsChange in sleep behavior based on Munich ChronoType Questionnaire (MCTQ)
Time frame:baseline, 6 and 12 months
change from baseline, descriptive
Change in physical activity based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame:baseline, 6 and 12 months
change from baseline, improvement
Change in muscle strength based on chair stand test
Time frame:baseline, 6 and 12 months
change from baseline, improvement
Change in binge eating disorder symptoms in binge eating disorder subgroup
Time frame:baseline and 12 months
change from baseline, improvement
Change in psychotropic medication use at 12 months in patients on psychotropic medication
Time frame:baseline and 12 months
categorical status, descriptive
Other (unclassified)
1 endpointExploratory: Identification of clinical, behavioral, and biological predictors of response using interpretable machine learning models
Time frame:Through study completion (up to 12 months after treatment initiation)
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Journal of neuroscience : the official journal of the Society for Neuroscience2025 Nov 12PMID41224657doi:10.1523/JNEUROSCI.1375-25.2025via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.