Tirzepatide in Idiopathic Intracranial Hypertension Trial

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  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 Placebo — DRUG
  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 Details

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.

Key Dates

First listed

Sep 25, 2025

Start date

Aug 25, 2026

Status verified

Sep 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Tirzepatide
  Participants 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
• Placebo Comparator: Placebo
  Participants 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

Primary Outcome Measure

Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients [ Time Frame: From enrollment to end of treatment at 12 months ]

Central Contacts

• Alexa N Bramall, MD
  919-660-1754
  [email protected]
• Beth Perry, RN
  919-681-2695
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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• Advanced Neuroimaging in Idiopathic Intracranial Hypertension
  Recruiting · Thomas Jefferson University · Philadelphia, Pennsylvania