NCT06027567

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rigmor Højland Jensen · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Idiopathic Intracranial Hypertension is primarily observed in obese female and weight management promotes disease control by yet unsettled mechanisms. Effective, fast and lasting weight loss is crucial, however, hard to achieve. Current weight management strategy in IIH in Denmark is counselling by a dietician. This study investigates whether an initial Very Low Calorie Diet (max 800 kcal/day) for 8 weeks following the diagnosis combined with GLP1-RA treatment throughout 10 months is tolerated and more efficient in achieving substantial weight loss and reduction of intracranial pressure. Furthermore, a number of secondary outcomes are measured including headache burden, quality of life, structure and function of the optic nerve, non-invasive surrogate markers of intracranial pressure, body fat mass, bone health, fatty liver disease and a range of cerebrospinal-, blood- and urine markers of i.a. the hormonal, inflammatory, metabolic, and headache biomarker profile. The intervention may candidate as a future first-line treatment regime.

Conditions

• Idiopathic Intracranial Hypertension
• Intracranial Pressure
• Obesity
• Pseudotumor Cerebri Syndrome
• Papilledema
• Weight Loss

Interventions

Type	Name	Description
DRUG	Semaglutide	Subcutaneous once-weekly injections of Semaglutide uptitrating to a maximum of 2.4 mg
DIETARY_SUPPLEMENT	Very Low Calorie Diet	Very Low Calorie Diet (max 800 kcal/day) using Nupo Diet meal replacement products
BEHAVIORAL	Dietician counselling	Counselling by a dietician on weight loss through behavioural changes and life style intervention

Timeline

• Start date: 2022-09-02
• Primary completion: 2025-01-28
• Completion: 2025-10-28
• First posted: 2023-09-07
• Last updated: 2026-02-27

Locations

2 sites across 1 country: Denmark