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

Sponsor
Rigmor Højland Jensen
Study ID
NCT06027567
Phase
PHASE4
Status
Completed

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — 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

Study Details

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)

Key Dates

Start date
Sep 2, 2022
Status verified
Oct 2025
Primary completion
Jan 28, 2025
Completion
Oct 28, 2025

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Semaglutide up-titration to 2.4 mg for 10 months initially combined with a Very Low Calorie Diet (800 kcal/day) for 8 weeks. Counselling by dietician Standard medical treatment of intracranial hypertension
  • Active Comparator: Standard care (dietician)
    Standard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension

Primary Outcome Measure

Weight [ Time Frame: 8 weeks ]

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