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

What Was Tested

The trial (phase 3) is built around Semaglutide.

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.

It had two arms (groups): SEMAGLUTIDE (experimental) and PLACEBO (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 12 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 12 to 17 years. Surgical treatmentsurgery for the solid area (non-cystic portion) of the tumor was \>6 months ago and whose tumor is considered stable. 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. 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). Subjects covered by or having the rights to medical care assurance.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: other weight loss treatments within 90 days before screening; previous surgical treatment for obesity; other chronic diseases.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-11 with completion listed for 2031-02.

It ran at 17 sites in France (17).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in BMI SD score (according to french references) at 40 weeks (time frame: 40 weeks). Change in BMI SD score (according to french references) at 80 weeks (time frame: 80 weeks).

It also tracked 21 secondary outcomes, for example Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo, Change in BMI in kg/m at 80 weeks between compared between semaglutide and placebo, Intra-individual progression of BMI-DS at each visit depending on Semaglutide treatment, Effects of 40 weeks of weekly semaglutide treatment on height, Effects of 40 weeks of weekly semaglutide treatment on weight and Effects of 40 weeks of weekly semaglutide treatment on waist circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 50 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.