Tirzepatide for Idiopathic Intracranial Hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, parallel-group trial enrolling 60 adults with idiopathic intracranial hypertension. Participants will receive tirzepatide or placebo in a 1:1 ratio for 12 months, with the primary goal of comparing the change in intracranial pressure from baseline between the two groups using ANCOVA, adjusting for initial ICP. Eligibility includes signs of increased ICP, BMI of 30 or higher, ages 18–60, and confirmed absence of secondary causes. The study is led by Duke University with collaborators including Eli Lilly, and is conducted at Duke University Medical Center in Durham, NC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signs and symptoms of increased intracranial pressure:

   1. headaches, tinnitus, visual obscurations, papilledema;
   2. absence of localizing findings on neurological examination (except for VI nerve palsy);
   3. no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;
   4. 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);
   5. the patient is awake and alert.
2. BMI ≥30 kg/m2
3. Age 18-60 years of age
4. Unilateral or bilateral papilledema
5. Able to provide informed consent
6. Women of child-bearing age must use birth control (non-oral contraceptive method or add a barrier method of contraception).

Exclusion Criteria:

1. Previous bariatric surgery
2. Prior intervention for high ICP including optic nerve sheath fenestration (ONSF), venous stenting and/or shunting
3. Taking another GLP-1 agonist, another drug that can interfere with the GLP-1 agonist, or any other anti-obesity medication
4. 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
5. Pregnancy or planning a pregnancy in the next 12 months or currently breastfeeding
6. Other disorders causing visual loss and/or anomalous optic nerve
7. 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)
8. No change in headache medications in the past 60 days
9. Venous sinus thrombosis on magnetic resonance venography (MRV)
10. Papilledema Frisen Grade III, IV or fulminant IIH
11. Mean perimetric deviation ≤ -7 dB
12. CSF contents outside of normal limits
13. Uncontrolled hypertension (≥140mmHg/90 mmHg)
14. Anemia (hemoglobin \[Hgb\] ≤ 8.0g/dL)
15. Diagnosed sleep apnea with continuous positive airway pressure (CPAP) use
16. Exposure to a drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines
17. eGFR \< 30 ml/min/1.73m2
18. Type II diabetes

Where it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Alexa N Bramall, MD — Duke University
• Study coordinator: Alexa N Bramall, MD
• Email: alexa.bramall@duke.edu
• Phone: 919-660-1754

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transverse sinus stenting for newly diagnosed idiopathic intracranial hypertension

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• Understanding the link between body mass index and treatment response in idiopathic intracranial hypertension

  This study is trying to see how body weight affects treatment success in people with idiopathic intracranial hypertension and what weight goals might help them feel better.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.