NCT07191873 Tirzepatide in Idiopathic Intracranial Hypertension Trial
| NCT ID | NCT07191873 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Idiopathic Intracranial Hypertension (IIH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-25 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2026-08-25 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility Criteria
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
Contact & Investigator
Alexa N Bramall, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07191873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Idiopathic Intracranial Hypertension (IIH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07191873 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07191873 currently recruiting?
Yes, NCT07191873 is actively recruiting participants. Contact the research team at alexa.bramall@duke.edu for enrollment information.
Where is the NCT07191873 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07191873 clinical trial?
NCT07191873 is sponsored by Duke University. The principal investigator is Alexa N Bramall, MD at Duke University. The trial plans to enroll 60 participants.