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 — IIH:DUAL  

Obesity Clinical Trial

Official title: Glucagon-like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as Treatment of Idiopathic Intracranial Hypertension

Status Recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06027567
• Study type: Interventional
• Source: Danish Headache Center
• Contact: Rigmor H Jensen, Professor
• Phone: 0045-38633059
• Email: rigmor.jensen@regionh.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2, 2022
• Completion date: December 31, 2025