RecruitingPhase IIIInterventional

IIH-Advance: A randomised clinical trial to determine the effects of weight loss, induced by a weight loss drug (Tirzepatide), in adults with active idiopathic intracranial hypertension

The 'IIH-Advance' study is investigating a new way to treat Idiopathic Intracranial Hypertension (IIH). IIH is a condition where there's too much pressure inside your head, often causing severe headaches and swelling behind your eyes. This swelling can even lead to vision loss. It mostly affects women of childbearing age who are overweight. While losing weight can improve IIH, it's often very difficult to do and maintain. This study will look at whether a weight loss drug called Tirzepatide, given as a weekly injection, can help people with IIH lose weight, reduce their head pressure, and improve their eye health. The study uses a common weight loss drug, but it's not yet approved specifically for IIH.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Birmingham

Enrolment target

Start

19 Jan 2026

Estimated completion

31 Jan 2027

Idiopathic intracranial hypertension

What is this study about?

Idiopathic Intracranial Hypertension (IIH) is a medical condition where the pressure of the fluid surrounding your brain and spinal cord becomes too high. We don't always know why this happens (that's what 'idiopathic' means). This increased pressure can lead to some really uncomfortable symptoms like severe, daily headaches, problems with your vision, and a condition called papilloedema, which is swelling at the back of your eyes. In some cases, if not managed, this swelling can even lead to permanent vision loss. IIH is more common in women of childbearing age, particularly those who are overweight.

Currently, there isn't a specific medication designed just for IIH. Existing treatments can be tricky to manage, and they don't always work for everyone. We know that losing weight can be a very effective way to lower the pressure inside the head and improve symptoms for people with IIH. However, losing weight and keeping it off through diet alone can be incredibly challenging, and weight loss surgery isn't suitable or wanted by everyone.

This study, called 'IIH-Advance', is exploring a newer approach. It's looking at a drug called Tirzepatide, which is already used to help people lose weight. The main idea is to see if taking Tirzepatide can help people with IIH reduce their weight, which in turn could lower the pressure inside their heads, ease their headaches, and improve the health of their eyes. If successful, this could offer a new, simpler treatment option for many people living with IIH.

Key takeaways

IIH causes high pressure in the head, leading to headaches and vision problems.
This study explores a weight loss drug (Tirzepatide) as a potential new treatment for IIH.
Participation involves weekly injections and regular eye health checks at Specsavers.
Potential benefits include better headaches and improved eye health; risks include drug side effects.
The study is for adults with IIH and specific weight requirements who have tried dieting before.

Who may be eligible?

To take part in this study, you need to be an adult (18 years or older) who has been diagnosed with Idiopathic Intracranial Hypertension (IIH). A key requirement is that you must also have swelling at the back of your eye, called papilloedema, which will be checked using eye scans. You will also need to have a Body Mass Index (BMI) of 30 or higher. If your IIH is clearly linked to weight gain, or if you belong to certain ethnic groups (like South Asian, Chinese, Black African, for example), your BMI could be 27 or higher.

Before joining, you'll need to confirm that you've tried to lose weight through dieting in the past but haven't been successful. You should also be able to give written permission to join the study.

There are also some reasons why you might not be able to join. For example, if you've recently had weight loss surgery, or if you've had surgery for IIH in the past. You can't take part if you're pregnant or breastfeeding, or if you plan to get pregnant during the study. People who have certain medical conditions like some types of cancer, particular heart problems, or a history of pancreatitis, or who are using certain diabetes medications or other weight loss injections, also cannot participate.

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 18 years old or older?
Have you been diagnosed with Idiopathic Intracranial Hypertension (IIH)?
Do you have swelling at the back of your eye (papilloedema) as confirmed by a doctor?
Is your Body Mass Index (BMI) 30 or higher (or 27+ if your IIH is linked to weight or you are from certain ethnic groups)?
Have you tried to lose weight through dieting before, without long-term success?
Are you able to give yourself a weekly injection (or have a carer help you)?
Are you NOT currently pregnant or breastfeeding, and not planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you'll first give your permission (consent) to take part. After that, you'll be randomly put into one of two groups. One group will receive the study medication, Tirzepatide, and the other group will receive standard care for IIH but no study drug. You won't get to choose which group you're in, as this is decided by chance.

The medication, Tirzepatide, is given as a weekly injection, which you'll learn to give yourself at home using an injection pen. This treatment period will last for six months. Throughout the study, you'll also continue to receive your usual medical care for IIH. A key part of the study involves having regular eye health checks using a special scanning machine called an OCT, which you'll have done at a local Specsavers optician. The study aims to run from January 2026 to October 2028, and you'll be involved during a portion of that time.

Potential risks and benefits

There are potential benefits and risks to consider if you're thinking about joining this study. The main potential benefit is that losing weight with Tirzepatide could lower the pressure inside your head, reduce your headaches, and improve your eye health, potentially preventing vision problems. However, it's important to be aware that the medication can have side effects, such as feeling sick (nausea) or other health issues. Also, if you stop taking the medication and regain weight, there's a chance your IIH symptoms could come back. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Birmingham
Approximate
Birmingham, England

Common questions

What is Idiopathic Intracranial Hypertension (IIH)?

IIH is a condition where the pressure of the fluid inside your skull becomes too high for no clear reason. This can cause severe headaches and affect your vision.

What is Tirzepatide?

Tirzepatide is a medicine that helps people lose weight. This study is testing if it can help people with IIH by reducing weight and improving their symptoms.

Will I know if I'm getting the drug or not?

No, you won't know initially. You'll be randomly assigned to either receive the study drug plus standard care or just standard care. This helps researchers get accurate results.

Where are the eye scans done?

Your eye health will be checked using special scans (OCTs) at a local Specsavers optician.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Lauren Sturdy

l.sturdy@bham.ac.uk +44 121 4158840 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.