Purpose of this Study
If you join this study, you will be randomly placed into one of two groups - one group will get the study medicine, and the other will get a placebo, which is a fake medicine. You will give yourself a shot once a week. The amount of medicine in the shot will go up every 4 weeks, starting at a small dose and going up to a bigger dose.
The study may last up to 12 months. During that time, doctors will check your health with tests like:
- Measuring your height, weight, and vital signs
- Taking blood samples
- Doing pregnancy tests
- Doing a spinal tap at the beginning and end of the study
- Eye exams
- Brain and nerve check-ups
- Surgery check-ups
- Help with nutrition, exercise, and healthy habits
- Keeping a diary about headaches and medicine
- Answering questions in surveys
Who Can Participate?
Eligibility
To join this study, people must be between 18 and 60 years old and have a body mass index (BMI) of 30 or higher. They must have signs of high pressure inside the head and swelling in one or both eyes. Women who can have children must use birth control that is not a pill or must add another method like a barrier.
People cannot join the study if they:
- Had weight loss surgery before
- Are taking another medicine like a GLP-1 agonist
- Have type 2 diabetes
If you want to learn more, you can contact the study team at ar477@duke.edu.
Age Range
18-60
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to find out if a medicine called tirzepatide can help lower the pressure inside the head in people with a condition called Idiopathic Intracranial Hypertension, or IIH. People with IIH often have headaches and vision problems because of too much fluid around the brain.
In the study, some people will get tirzepatide and others will get a placebo, which is a fake medicine. The study will last for 12 months. Doctors will check to see if the pressure in the head goes down more in the group that gets tirzepatide. They hope this medicine can help people feel better and protect their eyesight by lowering the pressure in the brain.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)
Principal Investigator
Alexa
Bramall
Protocol Number
PRO00117470
NCT ID
NCT07191873
Phase
IV
Enrollment Status
Open to Enrollment