Clinical trial · Interventional
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This hypothalamic obesity is associated with serious metabolic and psychosocial consequences. The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniopharyngiomas | Craniopharyngioma | ALIAS | 0.90 |
| Hypothalamic Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exenatide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exenatide
- description
- Treatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.
- interventionNames
- Drug: Exenatide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Compare body weight change thanks to weighing machine
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * They are between 18 and 75 yrs. * They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence. * They have a BMI upper than 30kg/m² with intractable weight gain following therapy for craniopharyngioma. * They demonstrate at least one other endocrinopathy, as a marker of hypothalamic damage. * All pituitary deficiencies are correctly treated. * They gave their written, informed consent before the beginning of the study. Exclusion Criteria: * They have type 1 diabetes. * They have type 2 diabetes treated with insulin. * Acidocetosis. * Bariatric surgery * Previous personal history of thyroid or pancreatic cancer. * Hypercalcitoninemia. * They have been previously treated by GLP1 analogs. * Hypertriglyceridemia upper than 5g/l * They had previously demonstrated voluntary weight loss during the three previous months. * They are under the age of 18 years or over the age of 65 yrs. * They are maintained on medical treatment against obesity. * They are receiving supraphysiologic hydrocortisone therapy (upper than 30 mg/jour). * Their GH status change during the course of the study. * Exenatide is contraindicated. * Psychological and/or medical problems that would create difficulties for the patient to comply with the study protocol are present.
References
Publications (1)
- RESULTGatta-Cherifi B, Mohammedi K, Cariou T, Poitou C, Touraine P, Raverot G, Brue T, Chanson P, Illouz F, Grunenwald S, Chabre O, Sonnet E, Cuny T, Bertherat J, Czernichow S, Frison E, Tabarin A. Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial. Eur J Endocrinol. 2024 Mar 30;190(4):257-265. doi: 10.1093/ejendo/lvae024. PMID 38450721