NCT06027567CompletedPhase 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
Glucagon-like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as Treatment of Idiopathic Intracranial Hypertension
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 23 Feb 2023
- Start date
- 2 Sept 2022
- Primary completion date
- 28 Jan 2025
- Lead sponsor
- Rigmor Højland Jensen
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT06027567
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 38
- From 2 Sept 2022 to the primary completion date, 28 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
Other illness
- Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
- 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
Other
- Unable to provide written informed consent or participate
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Headache Center, Department of Neurology, Rigshospitalet Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Headache clinic, Department of Neurology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.