Assessing efficacy and safety of exenatide in the treatment of hypothalamic obesity

Phase 1

• Conditions: Hypothalamic obesity after craniopharyngioma therapy.; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-004755-21-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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 > 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 > 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 (> 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified