Could a diabetes drug ease brain pressure?

NCT ID NCT07191873

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests whether tirzepatide, a drug used for diabetes and weight loss, can lower brain pressure in people with idiopathic intracranial hypertension (IIH). IIH causes high pressure inside the skull, leading to headaches, ringing in the ears, and vision problems. The trial will involve 60 participants who will receive either tirzepatide or a placebo for about 12 months, and researchers will measure changes in brain pressure and eye health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide
What this could lead to
If it works, this could provide a new treatment option to reduce brain pressure and improve symptoms like headaches and vision issues in people with idiopathic intracranial hypertension.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. Tirzepatide can cause side effects like nausea and vomiting, and it's unclear if it will effectively lower brain pressure long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

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