Idiopathic intracranial hypertension Circulatory System
Conditions
Interventions
Design Overview
IIH-Advance is a phase III, multi-stage, randomised controlled trial designed to evaluate whether weight loss induced by tirzepatide improves disease activity in adults with active idi
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of IIH as defined by the IIH consensus criteria 2. Age 18 years or older 3. No evidence of sight-threatening papilloedema requiring urgent surgical intervention 4. Presence of papilloedema in at least one eye measured by OCT RNFL 5. Body Mass Index (BMI) greater than or equal to: • 30.0 kg/sqm or • 27.0 kg/sqm with IIH associated with increased weight or • 27.0 kg/sqm and of South Asian, Chinese, other Asian, Middle Eastern, Black African or African Caribbean ethnicity\* 6. At least one self-reported unsuccessful dietary effort to lose body weight 7. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous bariatric surgery within the last 3 months or intention to undergo bariatric surgery during the trial 2. Previous surgery for IIH including optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and venous stenting 3. Using glucose-lowering medication 4. Currently taking or has received a GLP-1R agonist for any indication in the last 4 weeks 5. Previous or current pancreatitis 6. Contraindication to Tirzepatide (for example, previous or current medullary cancer, history of multiple endocrine neoplasia, active gall stones) 7. Current eating disorder requiring hospital intervention or treatment 8. Is unable to self-administer (or administer with carer support) the trial medication 9. Females of child-bearing potential only: • Pregnant (spot urine test will be performed before randomisation to rule out pregnancy) • Not willing to take highly effective contraceptive measures during the study intervention period AND for 5 weeks following the last trial medication dose • Not willing to stop breastfeeding once randomised into the trial
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLauren Sturdy
Outcome results
None listed