Craniopharyngioma, ChildPhase 3SEMAFORCRANIONCT07845994
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
A Phase 3 study testing Semaglutide (Wegovy) weekly injection in people with Craniopharyngioma, Child, run by University Hospital, Angers at 17 sites in France.
Trial summary
Craniopharyngioma (CP) is a rare embryonic brain tumor of the sellar and parasellar region. Despite its benign histologic characteristics, it is locally aggressive and may cause severe morbidity from invasion into adjacent tissues and structures. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Craniopharyngioma, Child
- What is being tested?
- Semaglutide (Wegovy) weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 17 sitesFrance
- Study dates
- Nov 2026to Feb 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites
Service Endocrinologie pédiatrique, Angers University Hospital
Angers
Régis COUTANT, Professor of Medecine, +33 (0)2.41.35.56.55, recoutant@chu-angers.fr
Endocrinologie Pédiatrique, University hospital of Besançon
Besançon, 25030
Brigitte MIGNOT, Doctor of Medecine, +33(0)3.81.21.91.81, bmignot@chu-besancon.fr
Service d'endocrinologie, diabétoglogie et obésité pédiatrique, Bordeaux University Hospital
Bordeaux
Pascal BARAT, Professor of Medecine, +33(0)5.56.79.87.25, pascal.barat@chu-bordeaux.fr
Endocrinologie Pédiatrique, Hôpital Femme Mere Enfants, Lyon University Hospital
Bron
Carine VILLANUEVA, Doctor of Medecine, +33(0)4.27.85.53.28, carine.villanueva@chu-lyon.fr
Département de Pédiatrie, Dijon University Hospital
Dijon
Candace BEN SIGNOR, Doctor of Medecine, +33(0)3.80.29.30.31, candace.bensignor@chu-dijon.fr
Service de Pédiatrie, Grenoble University Hospital
La Tronche
Cyril RUELLO, Doctor of Medecine, +33(0)4.76.76.89.02, CRuello1@chu-grenoble.fr
Endocrinologie et diabète de l'enfant, Hopital Bicêtre, Paris University Hospital
Le Kremlin-Bicêtre
Cécile TEINTURIER, Doctor of Medecine, +33(0)1.45.21.78.52, cecile.teinturier@aphp.fr
Endocrinologie, diabète et obésité pédiatrique, Lille University Hospital
Lille
Iva GUEORGUIEVA, Doctor of Medecine, +33(0)3.20.44.50.70, Iva.HUBERT@CHRU-LILLE.FR
Service de pédiatrie multidisciplinaire, Hopital La Timone, Marseille University Hospital
Marseille
Rachel REYNAUD, Professor of Medecine, +33(0)4.91.38.83.84, rachel.reynaud@ap-hm.fr
Service de diabétologie et endocrinologie pédiatriques
Montpellier
Essia JOYEZ, Doctor of Medecine, +33(0)4.67.33.65.06, e-joyez@chu-montpellier.fr
Unité Endocrinologie et Diabète, Nancy University hospital
Nancy
Emeline RENARD, Doctor of Medecine, +33(0)3.83.15.53.11, E.RENARD@chru-nancy.fr
Endocrinologie, diabétologie et Gynécologie pédiatrique, Necker Hospital, Paris University Hospital
Paris
Dulanjalee KARIYAWASAM, Doctor of Medecine, +33(0)1.44.49.48.02, dulanjalee.kariyawasam@aphp.fr
Service d'endocrinologie diabétologie pédiatrique, Paris University Hospital
Paris
Ahlam AZAR-KOLAKEZ, Doctor of Medecine, +33(0)1.40.03.41.20, ahlam.azar-kolakez@aphp.fr
Service de Pédiatrie A, Reims University Hospital
Reims
Aurélie BEROT, Doctor of Medecine, +33(0)3.26.78.94.78, aberot@chu-reims.fr
Unité d'Endocrinologie et Diabétologie Pédiatriques, Rennes University Hospital
Rennes
Marie-Béatrice SAADE, Doctor of Medecine, +33(0)2.99.26.71.34, Marie-beatrice.SAADE@chu-rennes.fr
Service de Pédiatrie, Strasbourg University Hospital
Strasbourg
Sylvie ROSSIGNOL, Professor of Medecine, +33(0)3.88.12.77.34, sylvie.rossignol@chru-strasbourg.fr
Unité d'Endocrinologie, Maladies Osseuses et Génétique, Toulouse University Hospital
Toulouse
Thomas EDOUARD, Professor of Medecine, +33(0)5.34.55.85.49, edouard.t@chu-toulouse.fr
About this study
Craniopharyngioma (CP) is a rare embryonic brain tumor of the sellar and parasellar region. Despite its benign histologic characteristics, it is locally aggressive and may cause severe morbidity from invasion into adjacent tissues and structures. Hypothalamic damage due to the tumor or its management is responsible for rapid and massive obesity, one of the most severe sequelae in patients with craniopharyngioma. Current treatment of craniopharyngioma is neurosurgical, possibly completed by radiotherapy. For preventing hypothalamic damage, surgery is the most "sparing" possible for the hypothalamus, possibly completed by a highly conformation radiation treatment, such as proton beam therapy.
Despite these therapeutic advances, obesity remains a significant problem in 30 to 50% of cases today. Most studies showed that the mean BMI at diagnosis of childhood craniopharyngioma was 0.5-0.8 ± 1.5 SD score, the mean BMI gain was +2 to +3 ± 2 SD score within 3 years, with a relative stabilization or a slow increase after 3 years. When there is an anterior and posterior hypothalamic involvement (about 50% of the cases), the mean BMI gain is even higher (+4 ± 3 SD score within 3 years).
Semaglutide, a GLP1RA in weekly injection, has shown its great effectiveness for losing weight in obese adults and adolescents (mean difference in BMI change - 16.7% with semaglutide vs. placebo after 68 weeks). Preliminary data in obese children with craniopharyngioma have shown a mean 25% difference in annual BMI gain (with semaglutide treatment compared to the previous year with no semaglutide in the same children).
- Conditions
- Craniopharyngioma, Child
- Being tested
- Semaglutide (Wegovy) weekly injection, Placebo weekly Injection
- Keywords
- Hypothalamic obesity, Pediatric disease, Craniopharyngioma
- Medical subject headings
- Craniopharyngioma, Sexual Infantilism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Wegovy) weekly injectionDrug
A 40-week randomized, controlled, double-blind semaglutide (versus placebo) intervention (versus placebo), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide.
In first 40 weeks period (0-40 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg.
In second 40 weeks period (40-80 weeks), Semaglutide is maintened at maximum tolerated dose form 1st period.
The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly.
Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended.
Placebo weekly InjectionDrug
A 40-week randomized, placebo double-blind controlled intervention (versus semaglutide injection), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide.
In first 40 weeks period (between 0-40 weeks), placebo is initiated in same timing than semaglutide (in other arm).
In second 40 weeks period (between 40-80 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg.
The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly.
Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended.
| Study group | Role | What they receive |
|---|---|---|
| SEMAGLUTIDE | Experimental | Not described Receives: Drug: Semaglutide (Wegovy) weekly injection |
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo weekly Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI SD score (according to french references) at 40 weeks
Co-primary 1 (S40 - RCT): Change in BMI (in SD for age and sex according to French references) after 40 weeks of treatment with semaglutide (dose escalation over 16 weeks followed by a maintenance dose of 2.4 mg/week for 24 weeks) compared to placebo
Measured: 40 weeks
Change in BMI SD score (according to french references) at 80 weeks
Co-primary 2 (S80 - delayed-start): Change in BMI-SD from baseline to S80: "semaglutide group starting at S0" vs "semaglutide group starting at S40"
Measured: 80 weeks
Secondary outcomes (21)
Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo
Evaluation of the variation in Body Mass Index (BMI), expressed in kg/m², from baseline (inclusion) to week 40. This will be compared between two groups: one receiving Semaglutide from the start of the study and the other receiving a placebo for the initial 40 weeks
Measured: 40 weeks
Change in BMI in kg/m at 80 weeks between compared between semaglutide and placebo
Evaluation of the variation in BMI, expressed in kg/m², from baseline (inclusion) to week 80. This will be compared between two groups: one receiving Semaglutide from the start of the study and the other receiving a placebo for the initial 40 weeks
Measured: 80 weeks
Intra-individual progression of BMI-DS at each visit depending on Semaglutide treatment
Intra-individual progression of BMI-SDS values measured at the scheduled visits outlined in the protocol from week 0 to week 80 depending on Semaglutide treatment periods.
Measured: 80 weeks
Effects of 40 weeks of weekly semaglutide treatment on height
Comparison of height between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on weight
Comparison of weight between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on waist circumference
Comparison of waist circumference between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on arterial blood pressure
Comparison of arterial blood pressure between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on fasting blood glucose
Comparison of fasting blood glucose between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on HbA1C
Comparison of HbA1C between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on insulin level
Comparison of insulin level between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on cholesterol
Comparison of cholesterol between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on triglycerides
Comparison of triglycerides between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on body composition
Comparison of body composition (by DEXA) between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on bone age
Comparison of bone age (by X-ray of the left hand and wrist) between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by PedsQL questionnaire
Comparison of quality of life by PedsQL questionnaire score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Epworth Sleepiness Scale
Comparison of quality of life by Epworth Sleepiness Scale score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by IWQOL-Kids questionnaire
Comparison of quality of life by IWQOL-Kids score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Dykens Hyperphagia questionnaire
Comparison of quality of life by Dykens Hyperphagia questionnaire score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Daily Hunger Score
Comparison of quality of life by Daily Hunger Score score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
Measured: 40 weeks
Safety between 2 arms
Comparison of the incidence of each category of adverse events (AE) between the two arms (semaglutide versus placebo).
Measured: 80 weeks
Kinetics of BMI-DS evolution
Difference in the kinetics of BMI (in DS) evolution depending on whether it occurs in the presence or absence of semaglutide
Measured: End of study V10 (106 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniopharyngioma, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Régis COUTANT, Professor of Medecine, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845994
- Sponsor's protocol ID
- 49RC23_0307
- Other IDs
- 2024-511114-20-00
- Acronym
- SEMAFORCRANIO
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07845994
- Acronym / sponsor ID
- SEMAFORCRANIO / 49RC23_0307
- Conditions
- Craniopharyngioma, Child
- Keywords
- Hypothalamic obesity, Pediatric disease, Craniopharyngioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Craniopharyngioma (CP) is a rare embryonic brain tumor of the sellar and parasellar region. Despite its benign histologic characteristics, it is locally aggressive and may cause severe morbidity from invasion into adjacent tissues and structures. Hypothalamic damage due to the tumor or its management is responsible for rapid and massive obesity, one of the most severe sequelae in patients with craniopharyngioma. Current treatment of craniopharyngioma is neurosurgical, possibly completed by radiotherapy. For preventing hypothalamic damage, surgery is the most "sparing" possible for the hypothalamus, possibly completed by a highly conformation radiation treatment, such as proton beam therapy.
Despite these therapeutic advances, obesity remains a significant problem in 30 to 50% of cases today. Most studies showed that the mean BMI at diagnosis of childhood craniopharyngioma was 0.5-0.8 ± 1.5 SD score, the mean BMI gain was +2 to +3 ± 2 SD score within 3 years, with a relative stabilization or a slow increase after 3 years. When there is an anterior and posterior hypothalamic involvement (about 50% of the cases), the mean BMI gain is even higher (+4 ± 3 SD score within 3 years).
Semaglutide, a GLP1RA in weekly injection, has shown its great effectiveness for losing weight in obese adults and adolescents (mean difference in BMI change - 16.7% with semaglutide vs. placebo after 68 weeks). Preliminary data in obese children with craniopharyngioma have shown a mean 25% difference in annual BMI gain (with semaglutide treatment compared to the previous year with no semaglutide in the same children).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMAGLUTIDE | Experimental | Drug: Semaglutide (Wegovy) weekly injection |
| PLACEBO | Placebo comparator | Drug: Placebo weekly Injection |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Wegovy) weekly injectionA 40-week randomized, controlled, double-blind semaglutide (versus placebo) intervention (versus placebo), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide. In first 40 weeks period (0-40 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg. In second 40 weeks period (40-80 weeks), Semaglutide is maintened at maximum tolerated dose form 1st period. The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly. Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended. | Drug | SEMAGLUTIDE |
| Placebo weekly InjectionA 40-week randomized, placebo double-blind controlled intervention (versus semaglutide injection), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide. In first 40 weeks period (between 0-40 weeks), placebo is initiated in same timing than semaglutide (in other arm). In second 40 weeks period (between 40-80 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg. The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly. Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended. | Drug | PLACEBO |
Primary outcome
Change in BMI SD score (according to french references) at 40 weeks
Time frame: 40 weeks
Co-primary 1 (S40 - RCT): Change in BMI (in SD for age and sex according to French references) after 40 weeks of treatment with semaglutide (dose escalation over 16 weeks followed by a maintenance dose of 2.4 mg/week for 24 weeks) compared to placebo
Change in BMI SD score (according to french references) at 80 weeks
Time frame: 80 weeks
Co-primary 2 (S80 - delayed-start): Change in BMI-SD from baseline to S80: "semaglutide group starting at S0" vs "semaglutide group starting at S40"
21 secondary outcomes
Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo
Time frame: 40 weeks
Change in BMI in kg/m at 80 weeks between compared between semaglutide and placebo
Time frame: 80 weeks
Intra-individual progression of BMI-DS at each visit depending on Semaglutide treatment
Time frame: 80 weeks
Effects of 40 weeks of weekly semaglutide treatment on height
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on weight
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on waist circumference
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on arterial blood pressure
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on fasting blood glucose
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on HbA1C
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on insulin level
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on cholesterol
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on triglycerides
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on body composition
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on bone age
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by PedsQL questionnaire
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Epworth Sleepiness Scale
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by IWQOL-Kids questionnaire
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Dykens Hyperphagia questionnaire
Time frame: 40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Daily Hunger Score
Time frame: 40 weeks
Safety between 2 arms
Time frame: 80 weeks
Kinetics of BMI-DS evolution
Time frame: End of study V10 (106 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Régis COUTANT, Professor of Medecine principal investigator
University Hospital of Angers
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide (Wegovy) weekly injection in people with Craniopharyngioma, Child, run by University Hospital, Angers at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regis COUTANT, Professor of Medecine (+ 33 (0)2 41 35 56 55, ReCoutant@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI SD score (according to french references) at 40 weeks (time frame: 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.