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Tirzepatide in Idiopathic Intracranial Hypertension Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide lowers pressure inside the skull over 12 months compared with a placebo, which has no active drug. It is for adults ages 18–60 with obesity and idiopathic intracranial hypertension (IIH), or high pressure inside the skull with no known cause. The study will include 60 people.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–60, with a body mass index (BMI) of 30 or higher.
  • Signs of high pressure inside the skull, such as headaches, ringing in the ears, brief vision changes, or swelling of the nerve at the back of the eye.
  • Swelling of the nerve at the back of one or both eyes.
  • A spinal tap pressure of at least 25 cm H2O, or at least 20 cm H2O with certain other signs. This is measured while lying on your side with legs straight.
  • Brain scans show no other cause of high pressure. The nerve exam shows no signs pointing to a specific brain problem, except an allowed problem with a nerve that controls eye movement.
  • Awake and alert.
  • Able to understand the study and agree to join.
  • Women who could become pregnant must use birth control that is not taken by mouth, or add a barrier method, such as condoms.

Who can't join

  • Past weight-loss surgery, or a procedure for high skull pressure, such as surgery around the eye nerve, a vein stent, or a shunt to drain fluid.
  • Use of another GLP-1 drug, a drug that interferes with it, or another weight-loss drug. Pressure-lowering medicine for IIH must be stopped at least 30 days before joining. The listing also names 'no change in headache medications in the past 60 days' as an exclusion; ask the study team to clarify.
  • Past pancreas inflammation, gallbladder disease, ulcerative colitis, Crohn’s disease, or an allergic reaction to the study drug. Personal or family history of medullary thyroid cancer or MEN2, a condition that can cause tumors in hormone-making glands.
  • Pregnant, planning pregnancy within 12 months, or breastfeeding.
  • Other causes of vision loss or an unusual eye nerve; eye nerve swelling at Frisen grade III or IV; rapidly worsening IIH; or a side-vision test score of −7 dB or lower.
  • A blood clot in a brain vein on a scan, or abnormal contents of the fluid around the brain and spinal cord. Exposure to a drug, substance, or condition linked to high skull pressure within 2 months of diagnosis also excludes you.
  • Uncontrolled blood pressure of 140/90 or higher; low red blood cells with hemoglobin of 8.0 g/dL or lower; or diagnosed sleep apnea treated with a CPAP breathing machine.
  • Kidney filtering rate (eGFR) below 30, or type 2 diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC