Status:
NOT_YET_RECRUITING
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Idiopathic Intracranial Hypertension (IIH)
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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-...
Eligibility Criteria
Inclusion
- Signs and symptoms of increased intracranial pressure:
- headaches, tinnitus, visual obscurations, papilledema;
- 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
- Unilateral or bilateral papilledema
- Able to provide informed consent
- Women of child-bearing age must use birth control (non-oral contraceptive method or add a barrier method of contraception).
Exclusion
- Previous bariatric surgery
- 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
- Venous sinus thrombosis on magnetic resonance venography (MRV)
- Papilledema Frisen Grade III, IV or fulminant IIH
- Mean perimetric deviation ≤ -7 dB
- CSF contents outside of normal limits
- Uncontrolled hypertension (≥140mmHg/90 mmHg)
- Anemia (hemoglobin \[Hgb\] ≤ 8.0g/dL)
- Diagnosed sleep apnea with continuous positive airway pressure (CPAP) use
- 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
- eGFR \< 30 ml/min/1.73m2
- Type II diabetes
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07191873
Start Date
February 1 2026
End Date
February 1 2028
Last Update
November 14 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710