IIH-Advance

• Research type

  Research Study

• Full title

  A phase III multi-stage randomised controlled trial to determine the effects of weight loss, induced by Tirzepatide, in adults with active idiopathic intracranial hypertension

• IRAS ID

  347499

• Contact name

  Alexandra Sinclair

• Contact email

  a.b.sinclair@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  3 years, 1 months, 31 days

• Research summary

  What is the trial about?
  The IIH-Advance trial is exploring whether weight loss, achieved using a medication called Tirzepatide, can help improve symptoms of a condition called Idiopathic Intracranial Hypertension (IIH). IIH causes raised pressure in the brain, which can lead to headaches and vision problems. It mainly affects women with obesity.

  Why is this important?
  There is no approved treatment that directly targets IIH. However, research shows that losing weight can help reduce brain pressure and improve symptoms. Dieting is often hard to maintain, and surgery isn’t suitable for everyone. Tirzepatide is a medication already approved and used in the NHS to support weight loss. This trial is investigating whether the weight loss it causes can lead to improvements in IIH.

  Who can take part?
  Adults with active IIH (confirmed by eye scans) and a high body mass index (BMI), who have previously tried and struggled to lose weight through dieting.
  What happens in the trial?
  • 86 participants will be randomly split into two groups:
  • One group receives Tirzepatide alongside usual care.
  • The other group receives usual care only.
  • The main goal is to see whether weight loss leads to a reduction in swelling of the optic nerve (a sign of raised brain pressure) after 6 months.
  • Eye scans will be done at Specsavers, and the medication is taken at home using weekly injections.

  What else is being studied?
  The trial will also look at:
  • Headaches, quality of life, and mental health.
  • What happens if people stop or restart the medication.
  • How weight loss affects sleep and body chemistry.
  • Participants’ experiences with weight management.

  How long does it last?
  Each person may be involved for up to 18 months, with monthly follow-up.
  

• REC name

  London - Central Research Ethics Committee

• REC reference

  25/LO/0799

• Date of REC Opinion

  10 Dec 2025

• REC opinion

  Further Information Favourable Opinion