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TIIHT
Not yet recruitingPhase 4Tirzepatide in Idiopathic Intracranial Hypertension Trial
A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
60
estimated
Study population
Obesity / overweight, Pseudotumor Cerebri
Key I/E criterion
•BMI ≥30
Primary endpoint
•Intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other clinical outcomes
4 endpointsChange in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Time frame:From enrollment to end of treatment at 12 months
change from baseline, improvement
Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT)
Time frame:From enrollment to end of treatment at 12 months
change from baseline, descriptive
Change in Frisen papilledema grade on fundus photography
Time frame:From enrollment to the end of treatment at 12 months
change from baseline, improvement
Change in perimetric mean deviation
Time frame:From enrollment to end of treatment at 12 months
change from baseline, improvement
Publications (5)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Journal of neurology, neurosurgery, and psychiatry2016 Sep (month)PMID26888960doi:10.1136/jnnp-2015-311302via CT.gov background
- Indian journal of ophthalmology2014 Oct (month)PMID25449938doi:10.4103/0301-4738.146012via CT.gov background
- International ophthalmology clinics2014 Winter (year)PMID24296367doi:10.1097/IIO.0b013e3182aabf11via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.