DelfaGLP-1 Atlas

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Recruiting

Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

7

Recruiting sites

1

Enrollment

70

estimated

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

—

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 IDNCT07302802
Org study IDU1111-1307-1203

Timeline

Milestones

Study start2025-12-01actual
Study first posted2025-12-24actual
Last update posted2026-01-08actual
Primary completion2028-06estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age21 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Patients aged ≥12 to \<21 years diagnosed with monogenic obesity, who agreed on treatment with semaglutide, are eligible for study participation.

Inclusion criteria

1. Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.

2. Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.

3. Age at time of signing informed consent: ≥12 to <21 years.

4. BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)

5. Body weight of >60 kg.

6. Diagnosis of monogenic obesity by a Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP)/International Organisation for Standardization (ISO) 1518-certified laboratory using ACMG criteria as pathogenic (P), likely pathogenic (LP) and variant of uncertain significance (VUS).

Exclusion criteria

1. Participation in any interventional clinical trials at the time of enrolment.

2. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)

3. Hypersensitivity to the active substance or to any of the excipients listed:

–Disodium phosphate, dihydrate
–Propylene glycol
–Phenol
–Hydrochloric acid (for pH adjustment)
–Sodium hydroxide (for pH adjustment)
–Water for injection

4. The safety and efficacy of Wegovy have not been investigated in patients:

–treated with other products for weight management,
–with type 1 diabetes,
–with severe renal impairment (see section 4.2),
–with severe hepatic impairment (see section 4.2),
–with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended

Endpoints (2)

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
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.

Time frame:68 weeks

≥10% weight-loss responders

threshold achievement, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint

Secondary Endpoints for Weight and Health Parameters

Time frame:68 weeks

descriptive

Publications (5)

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.