Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Glucagone Like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as treatment of Idiopathic Intracranial Hypertension

This research trial is investigating if special medications designed for weight loss, called Wegovy and Ozempic, can be an effective treatment for a condition known as Idiopathic Intracranial Hypertension (IIH). IIH is a condition where there's too much pressure in the fluid surrounding your brain. The study aims to find out if using these medications to help people lose weight quickly can reduce this brain pressure. They will be checking changes in brain pressure and body weight after 8 weeks, and then looking at longer-term effects after 10 months. They'll also be monitoring how it affects symptoms like headaches and vision. This is a Phase 4 study, meaning the drugs are already approved for other uses, but doctors are now studying them for IIH.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rigshospitalet

Enrolment target

Start

09 Dec 2024

Idiopathic Intracranial Hypertension

What is this study about?

This research study is looking into a condition called Idiopathic Intracranial Hypertension (IIH). This is when the pressure of the fluid around your brain becomes too high, which can cause symptoms like severe headaches and vision problems. Currently, weight loss is often a key part of managing IIH because it can help reduce this pressure.

In this study, researchers are exploring if certain medications, Wegovy and Ozempic, can help people with IIH lose weight quickly. These medications belong to a group of drugs that can help manage blood sugar and are also approved for weight management in some people. The main goal is to see if using these medications for rapid weight loss can lead to a significant drop in the pressure around the brain. They'll measure this after 8 weeks and then again after 10 months.

Beyond simply checking brain pressure and weight, the study will also look at many other aspects of IIH. This includes how it affects your vision (like swelling behind your eyes called papilledema), the frequency and severity of headaches, and your overall quality of life. They will also track if you need less headache medication and if you go into remission from the condition. By gathering all this information, doctors hope to understand if these weight-loss medications could be a helpful new way to treat IIH.

Key takeaways

Researchers are testing if weight-loss drugs can help treat Idiopathic Intracranial Hypertension (IIH).
The study medications are Wegovy and Ozempic, given by injection.
The main goals are to see if brain pressure and body weight significantly improve.
The study will also track headaches, vision, and quality of life over 10 months.
It's for adult women aged 18 and over who have been diagnosed with IIH.
You'll have regular check-ups, eye tests, and some medical procedures like lumbar punctures.

Who may be eligible?

This study is specifically designed for adult women aged 18 years and older. There isn't an upper age limit mentioned, so if you're an adult woman feeling unwell because of Idiopathic Intracranial Hypertension, this study might be for you.

To be considered, you would need to have received a diagnosis of Idiopathic Intracranial Hypertension (IIH) from your doctor. This means a medical professional would have confirmed you have this specific condition with high pressure around your brain.

Other specific health details would be checked by the study team to ensure the treatment is safe and appropriate for you. They will look at your full medical history to make sure you fit all the necessary requirements for the trial, as well as to confirm you don't have any conditions that would make taking these medicines unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman?
Are you 18 years old or older?
Have you been diagnosed with Idiopathic Intracranial Hypertension (IIH)?
Are you willing to take an injectable medication for weight loss?
Are you able to attend regular appointments for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be prescribed one of the study medications: Wegovy or Ozempic. These are given as an injection using a pre-filled pen. You would typically take this medication for the duration of the study.

Over the course of the study, you would attend several appointments. At these visits, doctors would perform various assessments. This includes procedures to check the pressure of the fluid around your brain (lumbar puncture), measure your body weight and body fat, and conduct detailed eye exams to check your vision. They would also ask you about your headaches, your general health, and your quality of life using questionnaires.

Blood and urine samples would be collected to check for specific markers related to your metabolism and general health. The study involves an initial period of 8 weeks on the medication, followed by a longer follow-up period, bringing the total study duration to 10 months. Throughout this time, your health and any effects of the medication would be carefully monitored.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as a reduction in the pressure around your brain and an improvement in your symptoms like headaches and vision problems as a result of weight loss. You would also receive regular medical monitoring and care from a specialist team. However, like all medications, Wegovy and Ozempic can have side effects. These can vary but might include nausea, vomiting, diarrhoea, or constipation. There are also less common but more serious risks associated with these drugs, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is Idiopathic Intracranial Hypertension (IIH)?

It's a condition where there's too much pressure in the fluid surrounding your brain, which can cause headaches and vision issues.

What are Wegovy and Ozempic?

These are medications approved for treating conditions like diabetes and for weight management, and they help with weight loss.

Why are these medications being studied for IIH?

Because losing weight often helps improve IIH, researchers want to see if these weight-loss medications can effectively reduce brain pressure.

How long will the study last?

The main part of the study measures changes after 8 weeks, with a full follow-up period lasting 10 months.

Will I have to have an injection?

Yes, the study medications (Wegovy and Ozempic) are given as an injection using a pre-filled pen.