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Could a diabetes drug ease pressure in the brain?

NCT ID NCT06027567

Disease control Sponsor: Rigmor Højland Jensen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 4 trial tested whether a rapid weight loss program using semaglutide (Ozempic/Wegovy) plus a very low calorie diet can help people with idiopathic intracranial hypertension (IIH), a condition where high pressure in the skull causes headaches and vision problems. 38 participants with new-onset IIH and a BMI of 27 or higher were randomly assigned to either standard diet counselling or the intensive program. The study measured weight change and intracranial pressure to see if the approach could reduce symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Semaglutide (also known as Ozempic, Wegovy) combined with a very low calorie diet and dietician counselling
What this could lead to
If successful, this could offer a new weight-loss-based treatment to reduce intracranial pressure and improve symptoms in people with idiopathic intracranial hypertension.
What could go wrong
This is a small, completed phase 4 trial with only 38 participants, so results may not apply to everyone. The very low calorie diet is intense and may be hard to follow, and semaglutide can cause side effects like nausea and vomiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

38 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria * BMI ≥ 27 * Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide * Written, informed consent Exclusion Criteria: * 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 * Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events * Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy) * History or family history of thyroid carcinomas or Multiple Endocrine Neoplasias (MEN1/MEN2) * History of bariatric surgery * Known hypersensitivity to any contents of Semaglutide® * Other severe/uncontrolled mental or physical disease

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Conditions

The condition(s) this trial relates to.

intracranial hypertension Obesity obesity disorder optic papillitis pseudotumor cerebri Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic intracranial hypertension Intracranial pressure Obesity Papilledema Pseudotumor cerebri syndrome Weight loss

Contacts and locations

Locations

  • Danish Headache Center, Department of Neurology, Rigshospitalet

    Glostrup Municipality, 2600, Denmark

  • Headache clinic, Department of Neurology, Odense University Hospital

    Odense, Odense, 5000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.