The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracrania… (NCT06027567) | Clinical Trial Compass
CompletedPhase 4
The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure
Denmark38 participantsStarted 2022-09-02
Plain-language summary
50 patients with verified new-onset Idiopathic Intracranial Hypertension are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous injections with Semaglutide for 10 months combined, in the initial 8 weeks following diagnosis, with a Very Low Calorie-Diet (max 800 kcal/day)
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria
* BMI ≥ 27
* Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide
* Written, informed consent
Exclusion Criteria:
* Unable to provide written informed consent or participate
* Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
* Pregnancy or breastfeeding
* Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
* Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy)
* History or family history of thyroid carcinomas or Multiple Endocrine Neoplasias (MEN1/MEN2)
* History of bariatric surgery
* Known hypersensitivity to any contents of Semaglutide®
* Other severe/uncontrolled mental or physical disease