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TIIHT

Not yet recruitingPhase 4

Tirzepatide in Idiopathic Intracranial Hypertension Trial

A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)

Lead sponsor

Duke University

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

NCT IDNCT07191873
Org study IDPro00117470

Timeline

Milestones

Study first posted2025-09-25actual
Last update posted2025-11-14actual
Study start2026-02estimated (month precision)
Primary completion2027-02estimated (month precision)
Study completion2028-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPseudotumor Cerebri

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

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 endpoints
Primary/protocol endpoint

Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients

Time frame:From enrollment to end of treatment at 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Secondary/protocol endpoint

Change in Frisen papilledema grade on fundus photography

Time frame:From enrollment to the end of treatment at 12 months

change from baseline, improvement

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.