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

What Was Tested

This registered phase 4 trial tested Semaglutide for fat loss, obesity & body recomposition.

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).

It had two arms (groups): Semaglutide (experimental) and Standard care (dietician) (active comparator).

Standard weight loss intervention Counselling by dietician Standard medical treatment of intracranial hypertension.

The registry classes the interventions as behavioral, dietary supplement and drug.

More on the Plan

Idiopathic Intracranial Hypertension is primarily observed in obese female and weight management promotes disease control by yet unsettled mechanisms.

Current weight management strategy in IIH in Denmark is counselling by a dietician.

The intervention may candidate as a future first-line treatment regime.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria. BMI ≥ 27. Written, informed consent.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: unable to provide written informed consent or participate; malignant iih with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting; pregnancy or breastfeeding.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-09-02 with completion listed for 2025-01-28.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight (time frame: 8 weeks). Intracranial pressure (time frame: 8 weeks). Intracranial pressure (time frame: 8 weeks).

It also tracked 56 secondary outcomes, for example Weight, Intracranial Pressure, Intracranial Pressure, Quality of Life, Headache burden measured by HURT questionnaire and Change in Papilledema.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 38 people with fat loss, obesity & body recomposition.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.