SEMAFORCRANIO

Not yet recruitingPhase 3

SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years

Lead sponsor

University Hospital, Angers

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Hypothalamic / syndromic obesity, Reproductive / infertility

Eligibility highlights

•Age 12-17

Primary endpoint

•BMI SD score

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07845994

Org study ID49RC23_0307

Secondary ID2024-511114-20-00

Timeline

Milestones

Study first posted2026-09-29actual

Last update posted2026-09-29actual

Study start2026-11estimated (month precision)

Primary completion2031-02estimated (month precision)

Study completion2031-02estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Hypothalamic / syndromic obesityReproductive / infertility

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 12 to 17 years

Treated craniopharyngioma whose last intervention was >6 months ago and whose tumor is considered stable with :

•surgical treatmentsurgery for the solid area (non-cystic portion) of the tumor was >6 months ago and whose tumor is considered stable

•irradiation treatment

-Appropriate pituitary replacements (including recombinant growth hormone replacement in case of growth hormone deficiency), as assessed by the attending child's physician, according to international recommendations.

-BMI > + 2 SD of the French references (overweight and obesity) or BMI gain ≥ + 1 SD over the past 6 to 12 months (in the absence of overweight or obesity)

-Failure to control weight despite strict adherence to dietary guidelines for at least six months (healthy nutrition and physical activity counseling provided by a dietician or other qualified healthcare professional)

-For women patients with spontaneous menarche (without the use of hormone treatment with oestrogens), highly effective contraceptive methods during all study participation (and until 7 weeks after last study drug intake)

-Subjects covered by or having the rights to medical care assurance

-Written consent signed by the parents or legally acceptable representatives of the subject, and child participation agreement

Exclusion criteria

•Other weight loss treatments within 90 days before screening

•Previous surgical treatment for obesity

•Other chronic diseases

•History of pancreatitis (acute or chronic, regardless of the number of years)

•Severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)

•Mental retardation

•A lifetime history of suicidal attempt

•History of NEM2 or medullary thyroid carcinoma, malignant neoplasms/carcinomas in situ, or uncontrolled thyroid disease

•Inability to understand the study

•Major problem of compliance with existing treatments (suggesting that compliance with the protocol will be insufficient)

•Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria which, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

•Known or suspected abuse of alcohol or recreational drugs

•History of type 1 or type 2 diabetes

•Patient with severe renal insufficiency (eGFR < 30 mL/min/1,73m2)

•Patient with hepatic impairment (mild to severe)

•Participation in another interventional research modifying management or likely to influence the study's assessment criteria

•Pregnancy or desire of pregnancy, breast-feeding patients and parturients

Endpoints (23)

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

Patient-reported / QoL

Glycemic / diabetes

Cardiometabolic biomarkers

Other (unclassified)

Safety / tolerability / PK

Weight & body composition

9 endpoints

Primary/protocol endpoint

Change in BMI SD score (according to french references) at 40 weeks

Time frame:40 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in BMI SD score (according to french references) at 80 weeks

Time frame:80 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo

Time frame:40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI in kg/m at 80 weeks between compared between semaglutide and placebo

Time frame:80 weeks

change from baseline, improvement

Secondary/protocol endpoint

Intra-individual progression of BMI-DS at each visit depending on Semaglutide treatment

Time frame:80 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on weight

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on waist circumference

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on body composition

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Kinetics of BMI-DS evolution

Time frame:End of study V10 (106 weeks)

descriptive

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on fasting blood glucose

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on HbA1C

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on insulin level

Time frame:40 weeks

descriptive

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on arterial blood pressure

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on cholesterol

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on triglycerides

Time frame:40 weeks

descriptive

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on quality of life by PedsQL questionnaire

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on quality of life by Epworth Sleepiness Scale

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on quality of life by IWQOL-Kids questionnaire

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on quality of life by Dykens Hyperphagia questionnaire

Time frame:40 weeks

descriptive

Secondary/protocol endpoint

Effects of 40 weeks of weekly semaglutide treatment on quality of life by Daily Hunger Score

Time frame:40 weeks

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety between 2 arms

Time frame:80 weeks

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Effects of 40 weeks of weekly semaglutide treatment on height

Time frame:40 weeks

descriptive

Secondary/protocol endpoint/low confidence

Effects of 40 weeks of weekly semaglutide treatment on bone age

Time frame:40 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.