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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-27

No results posted yet for this study

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)

Conditions

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Rigmor Højland Jensen

    lead OTHER

Principal Investigators

  • Rigmor H Jensen, Professor · Danish Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2025-01-28
Completion
2025-10-28

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027567 on ClinicalTrials.gov