DelfaGLP-1 Atlas

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ObGeSema

Recruiting

Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema)

A Multicenter Pharmacoepidemiological Cohort on Real Life Use of WEGOVY (Semaglutide) in Obese Patients With Monogenic Obesity

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

1

Enrollment

175

estimated

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Weight and Body Mass Index (BMI)

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 IDNCT06380426
Org study IDAPHP230441
Secondary IDIDRCB : 2023-A02003-42ANSM

Timeline

Milestones

Study first posted2024-04-23actual
Study start2024-09-19actual
Last update posted2025-08-07actual
Primary completion2027-04-30estimated
Study completion2027-11-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adults (≥18 years) with monogenic obesity due to a pathogenic variant already treated or with the physician's decision to initiate treatment with Semaglutide 2.4mg/week (WEGOVY®) in the standard care. Patients under legal protection and State Medical Assistance (AME) will be included.

Inclusion criteria

•Adult Patients (≥18 years)having already initiated a treatment with SEMAGLUTIDE (WEGOVY®) or with a physician's decision to initiate treatment in the standard care in the near future. All patients having initiated a treatment will be proposed to participate, including those having already stopped the treatment at the time of study initiation.
•Confirmation of monogenic obesity, as practiced in clinical routine, by the presence of a pathogenic or likely pathogenic variant in a gene with leptin-melanocortin pathway described in PNDS (https://www.has-sante.fr/jcms/p_3280217/fr/generique-obesites-de-causes-rares)
•Patients duly informed and not objecting to participate in the study
•Patients affiliated to a social security scheme or State Medical Assistance (AME).

Exclusion criteria

•Pregnant and breastfeeding women

Endpoints (15)

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

Patient-reported / QoL
9
Weight & body composition
3
Other clinical outcomes
2
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change in weight and Body Mass Index (BMI)

Time frame:From baseline (T0) to T12

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in weight and Body Mass Index (BMI)

Time frame:From baseline (T0) to 6 and/or 24 and/or 36 and/or 48 and/or 60 months

threshold achievement, improvement

componentsBody weight, % change, BMI, change

Secondary/protocol endpoint

Reduction of body weight equal to or above 5%

Time frame:From baseline (T0) to 6 and/or 12 and/or 24 and/or 36 and/or 48 and/or 60 months

≥5% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

9 endpoints
Secondary/protocol endpoint/low confidence

Change in Hunger score

Time frame:From baseline (T0) to 12 and/or 24 and/or 36 and/or 48 and/or 60 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behaviour measured by Food Craving questionnaire

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behaviour measured by the Binge Eating Scale (BES)

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ)

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behaviour measured by the Dykens questionnaire

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ)

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Digestive disorders (GIQLI )

Time frame:From baseline (T0) to 12 and/or 24 and/or 36 and/or 48 and/or 60 months

change from baseline, improvement

Secondary/protocol endpoint

Change in score of quality of life scores (patient and parents)

Time frame:From baseline (T0) to 12 months

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in anxiety and depression score

Time frame:From baseline (T0) to 12 and/or 24 and/or 36 and/or 48 and/or 60 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame:From baseline (T0) to 6 and/or 12 and/or 24 and/or 36 and/or 48 and/or 60 months

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Change in the International physical activity questionnaire (IPAQ - short form)

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in sleep disorder (MCTQ score)

Time frame:From baseline (T0) to 12 months

change from baseline, improvement

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.