Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

What Was Tested

This registered phase 3 trial tested Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Usual treatment (active comparator).

Usual treatment refers to the 2018 consensus guidelines on the management of IIH.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Idiopathic intracranial hypertension (IIH) is a condition characterized by elevated pressure within the skull for reasons that are not yet understood.

This condition does not involve abnormalities in the cerebrospinal fluid or any structural brain damage.

Recent studies have indicated that glucagon-like peptide-1 receptor agonists show promise as a potential treatment option for IIH.

Semaglutide, as a long-acting glucagon-like peptide-1 formulation, has a half-life of up to 160 hours and only needs to be injected once a week.

Who Took Part

Enrollment: 74 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age range from 18 to 75 years old, both male and female. Confirmed definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria. Voluntarily sign a written informed consent form.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: pregnant or breastfeeding women; currently using any hypoglycemic drugs, including glucagon like peptide-1 receptor agonists; known to be allergic to the active ingredients or any excipients in semaglutide.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2024-05-01 with completion listed for 2024-12-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intracranial pressure (time frame: 12 weeks). Adverse reactions (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Headache severity, Degree of papilledema, Perimetric mean deviation, Optic nerve sheath diameter and Body mass index.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 74 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.