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SEMASEARCH

Completed

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

14

Recruiting sites

Enrollment

1,100

actual

Study population

Obesity / overweight

Key I/E criteria

BMI ≥40Established 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

NCT IDNCT05897398
Org study ID69HCL22_0954

Timeline

Milestones

Study first posted2023-06-09actual
Study start2024-06-10actual
Primary completion2025-06-10actual
Study completion2025-06-10actual
Last update posted2025-09-02actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

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

Inclusion Criteria Male or female

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:

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

4 Older patients:

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1. Age > 60 years

5 Patients with extreme obesity:

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
Patient-reported / QoL
6
Other clinical outcomes
5
Glycemic / diabetes
1
MASH / liver
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of responders at Month 12

Time frame:12 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Difference in lean mass between sarcopenic and non-sarcopenic patients

Time frame:baseline, 6 and 12 months

Lean mass

descriptive, improvement

Secondary/protocol endpoint

Change in body weight in each subpopulation

Time frame:baseline, 6 and 12 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Proportion of responders by subpopulation at Month 12

Time frame:baseline and 12 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in prevalence of extreme obesity

Time frame:baseline and 12 months

threshold achievement, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

Difference in muscle strength between sarcopenic and non-sarcopenic patients

Time frame:Baseline, 6 months, and 12 months

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Evolution 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 endpoint
Secondary/protocol endpoint

Evolution 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 endpoint
Secondary/protocol endpoint

Evolution 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 endpoints
Secondary/protocol endpoint

Change in binge eating and eating behavior

Time frame:baseline, 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in quality of life

Time frame:baseline, 6 and 12 months

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Time frame:baseline, 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in hunger based on Hunger Score

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number 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 endpoints
Secondary/protocol endpoint

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

Time frame:baseline, 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in muscle strength based on chair stand test

Time frame:baseline, 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in binge eating disorder symptoms in binge eating disorder subgroup

Time frame:baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Other/protocol endpoint/low confidence

Exploratory: 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.