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

NCT06027567 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the anti-obesity drug semaglutide helps people with a condition called idiopathic intracranial hypertension (IIH) lose weight compared to standard weight management with a dietician.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 38 people

Who can join Ages 18–65 · female only

Timeline Started 2022-09 · est. completion 2025-10

Where 2 sites · Denmark

What this study is testing ClinicalTrials.gov NCT06027567 ↗

Description as written by the study sponsor.

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)

Treatments tested

Semaglutide also known as Ozempic, Wegovy Drug

Subcutaneous once-weekly injections of Semaglutide uptitrating to a maximum of 2.4 mg
Very Low Calorie Diet Dietary supplement

Very Low Calorie Diet (max 800 kcal/day) using Nupo Diet meal replacement products
Dietician counselling Behavioral

Counselling by a dietician on weight loss through behavioural changes and life style intervention

Main thing measured	Weight
Sponsor	Rigmor Højland Jensen
Conditions studied	Idiopathic Intracranial Hypertension, Intracranial Pressure, Obesity, Pseudotumor Cerebri Syndrome, Papilledema, Weight Loss
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06027567 ↗