drugset / Trial / NCT02860923

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

NCT02860923 ↗

Phase 3 Completed 42 enrolled University Hospital, Bordeaux
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2017-01-11
Primary completion
2018-06-30
Completion
2018-09-30

Outcome

Missed primary endpoint

paper The adjusted mean treatment difference was -3.1 kg (95% confidence interval [CI] -7.0 to 0.7, P = 0.11). PMID 38450721 ↗

paper Combined with intensive lifestyle interventions, a 26-week treatment with exenatide was not demonstrated superior to placebo to treat craniopharyngioma-related obesity. PMID 38450721 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 10 ug Subcutaneous