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
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: cardiovascular, cancer, other_emerging
- Who it enrolls
- age 18 Years to 65 Years; female; excludes diabetes; BMI ≥27 required; conditions: Idiopathic Intracranial Hypertension; Intracranial Pressure; Obesity; Pseudotumor Cerebri Syndrome
- Interventions
- Semaglutide; Very Low Calorie Diet; Dietician counselling
- Conditions
- Idiopathic Intracranial Hypertension; Intracranial Pressure; Obesity; Pseudotumor Cerebri Syndrome; Papilledema; Weight Loss
- Phase and size
- Phase 4 · 38 participants
- Dates
- Start 2022-09-02
Primary completion 2025-01-28 - Sponsor
- Rigmor Højland Jensen (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Weight8 weeks
- Intracranial pressure8 weeks
- Intracranial pressure8 weeks
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.