NCT06027567View on ClinicalTrials.gov

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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 2, 2022

Primary Completion Date

January 31, 2025

Study Completion Date

October 30, 2025

Conditions
Idiopathic Intracranial HypertensionIntracranial PressureObesityPseudotumor Cerebri SyndromePapilledemaWeight Loss
Interventions
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

Trial Locations (2)

2600

Danish Headache Center, Department of Neurology, Rigshospitalet, Glostrup Municipality

5000

Headache clinic, Department of Neurology, Odense University Hospital, Odense

All Listed Sponsors
collaborator

Rigshospitalet, Denmark

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

University of Copenhagen

OTHER

lead

Rigmor Højland Jensen

OTHER