Tirzepatide in Idiopathic Intracranial Hypertension Trial
United States60 participantsStarted 2026-02
Plain-language summary
This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Signs and symptoms of increased intracranial pressure:
✓. absence of localizing findings on neurological examination (except for VI nerve palsy);
✓. no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;
✓. elevated lumbar puncture (LP) opening pressure (OP) ≥25 cm H2O in lateral decubitus position with legs extended (\>= (≥ 20cm H2O if one of the following is present: pulse synchronous tinnitus, abducens palsy, Frisen grade II papilledema, transverse venous sinus stenosis, partially empty sella or enlarged optic nerve sheath on magnetic resonance imaging (MRI);
✓. the patient is awake and alert.
✓. BMI ≥30 kg/m2
✓. Age 18-60 years of age
Exclusion criteria
✕. Previous bariatric surgery
What they're measuring
1
Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Timeframe: From enrollment to end of treatment at 12 months
. Prior intervention for high ICP including optic nerve sheath fenestration (ONSF), venous stenting and/or shunting
✕. Taking another GLP-1 agonist, another drug that can interfere with the GLP-1 agonist, or any other anti-obesity medication
✕. History of pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), history of gallbladder disease, ulcerative colitis, Crohn's disease, or history of hypersensitivity reaction in response to the drug
✕. Pregnancy or planning a pregnancy in the next 12 months or currently breastfeeding
✕. Other disorders causing visual loss and/or anomalous optic nerve
✕. Taking another medication to lower ICP in IIH (if previously taking another medication for ICP must be off this medication for at least 30 days prior to enrollment)
✕. No change in headache medications in the past 60 days