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Idiopathic Intracranial Hypertension (IIH)Phase 4TIIHTNCT07191873

Tirzepatide in Idiopathic Intracranial Hypertension Trial

A Phase 4 study testing Tirzepatide in people with Idiopathic Intracranial Hypertension (IIH), run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Tirzepatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
25 Aug 2026to Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexa N Bramall, MD contact

919-660-1754

alexa.bramall@duke.edu

Beth Perry, RN contact

919-681-2695

beth.perry@duke.edu

United States1 site, 1 recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Alexa N Bramall, MD, 919-660-1754, alexa.bramall@duke.edu

    Beth Perry, RN, 919-681-265, beth.perry@duke.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Tirzepatide, Tirzepatide Placebo
Keywords
IIH, BMI, Eye Pressure, Headache
Medical subject headings
Pseudotumor Cerebri, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months

  • Tirzepatide PlaceboDrug

    Dosage Treatment time 2.5mg/0.5mL: 4 Weeks 5mg/0.5mL: 4 Weeks 7.5mg/0.5mL: 4 Weeks 10mg/0.5mL: 4 Weeks 12.5mg/0.5mL: 4 weeks 15mg/0.5 mL: 7 Months

Study groups in NCT07191873
Study groupRoleWhat they receive
TirzepatideActive comparatorParticipants receive Tirzepatide weekly on the following dose schedule for a year: Dosage Treatment time 2.5mg/0.5mL: Month 1 (4 Weeks) 5mg/0.5mL: Month 2 (4 Weeks) 7.5mg/0.5mL: Month 3 (4 Weeks) 10mg/0.5mL: Month 4 (4 Weeks) 12.5mg/0.5mL: Month 5-6 15mg/0.5 mL: Month 7-12
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants receive Tirzepatide Placebo weekly on the following dose schedule for a year: Dosage Treatment time 2.5mg/0.5mL: Month 1 (4 Weeks) 5mg/0.5mL: Month 2 (4 Weeks) 7.5mg/0.5mL: Month 3 (4 Weeks) 10mg/0.5mL: Month 4 (4 Weeks) 12.5mg/0.5mL: Month 5-6 15mg/0.5 mL: Month 7-12
Receives: Drug: Tirzepatide Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.

    Measured: From enrollment to end of treatment at 12 months

Secondary outcomes (3)

  1. Retinal Nerve Fiber Layer (RNFL) Thickness on optical coherence tomograhy (OCT)

    Mean change in RNFL thickness

    Measured: From enrollment to end of treatment at 12 months

  2. Change in Frisen papilledema grade on fundus photography

    The Frisen scale ranges from 0 (normal optic disc) to 5 (severe degree of edema).

    Measured: From enrollment to the end of treatment at 12 months

  3. Change in perimetric mean deviation

    Perimetric Mean Deviation (MD) is a key visual field index that represents the average point-by-point difference between a patient's visual field and the normal, age-matched expected visual field.

    Measured: From enrollment to end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start25 Aug 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07191873
Sponsor's protocol ID
Pro00117470
Acronym
TIIHT
Status last verified
Sep 2026
First submitted
17 Sep 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spitze A, Lam P, Al-Zubidi N, Yalamanchili S, Lee AG. Controversies: Optic nerve sheath fenestration versus shunt placement for the treatment of idiopathic intracranial hypertension. Indian J Ophthalmol. 2014 Oct;62(10):1015-21. doi: 10.4103/0301-4738.146012.

    PubMed 25449938

  • Chen J, Wall M. Epidemiology and risk factors for idiopathic intracranial hypertension. Int Ophthalmol Clin. 2014 Winter;54(1):1-11. doi: 10.1097/IIO.0b013e3182aabf11. No abstract available.

    PubMed 24296367

  • Mollan SP, Ali F, Hassan-Smith G, Botfield H, Friedman DI, Sinclair AJ. Evolving evidence in adult idiopathic intracranial hypertension: pathophysiology and management. J Neurol Neurosurg Psychiatry. 2016 Sep;87(9):982-92. doi: 10.1136/jnnp-2015-311302. Epub 2016 Feb 17.

    PubMed 26888960

  • Miah L, Strafford H, Fonferko-Shadrach B, Hollinghurst J, Sawhney IMS, Hadjikoutis S, Rees MI, Powell R, Lacey A, Pickrell WO. Incidence, Prevalence, and Health Care Outcomes in Idiopathic Intracranial Hypertension: A Population Study. Neurology. 2021 Feb 22;96(8):e1251-e1261. doi: 10.1212/WNL.0000000000011463.

    PubMed 33472926

  • Mollan SP, Aguiar M, Evison F, Frew E, Sinclair AJ. The expanding burden of idiopathic intracranial hypertension. Eye (Lond). 2019 Mar;33(3):478-485. doi: 10.1038/s41433-018-0238-5. Epub 2018 Oct 24.

    PubMed 30356129

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirzepatide in people with Idiopathic Intracranial Hypertension (IIH), run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexa N Bramall, MD (919-660-1754, alexa.bramall@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients (time frame: From enrollment to end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07191873, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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