NCT07191873 · Duke University
Tirzepatide in Idiopathic Intracranial Hypertension Trial
(TIIHT)
What this study is about
This will be a randomly assigned, where neither patients nor doctors know which treatment is given, parallel, compared against an inactive treatment trial of 60 participants.
View original scientific description
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.
Interventions
DRUG
Tirzepatide
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
DRUG
Tirzepatide Placebo
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
Primary outcome measures
Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Time frame: From enrollment to end of treatment at 12 months
Assessed by opening pressure via lumbar puncture (LP) in the left lateral decubitus position and measured in cm H2O.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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).
Exclusion criteria
- 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
- 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
Where
- Durham, North Carolina
Collaborators
Eli Lilly and Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations