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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511114-20-00

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma

Brief summary

Change in BMI (in standard deviations for age and sex according to French reference values) after 40 weeks of semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week for 24 weeks) compared to placebo. treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks) versus placebo, Evolution of BMI-DS between baseline and S80: “semaglutide from S0” arm vs “semaglutide from S40” arm.

Interventions

DRUGSemaglutide Placebo (Wegovy 2.4 mg solution for injection in pre-filled pen

DRUGWegovy 2.4 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change in BMI (in standard deviations for age and sex according to French reference values) after 40 weeks of semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week for 24 weeks) compared to placebo. treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks) versus placebo, Evolution of BMI-DS between baseline and S80: “semaglutide from S0” arm vs “semaglutide from S40” arm.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 28, 2026