Current partner codePEPTIDESDE
NCT07191873·Phase 4·INTERVENTIONAL

Tirzepatide in Idiopathic Intracranial Hypertension Trial

Status

Not yet recruiting

Phase

Phase 4

Enrollment

60

Locations

1

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Sep 25, 2025

  2. Study start

    Aug 2026

  3. Primary completion

    Aug 2027

  4. Study completion

    Aug 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 28, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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

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

Mean change in RNFL thickness

Change in Frisen papilledema grade on fundus photography

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

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

Change in perimetric mean deviation

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Duke University Medical Center

Durham, North Carolina, United States

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

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