Study on Semaglutide and Low-Calorie Diet for Weight Loss in Patients with New-Onset Idiopathic Intracranial Hypertension

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What is this study about?

This clinical trial is focused on studying a condition called Idiopathic Intracranial Hypertension (IIH), which is a disorder characterized by increased pressure around the brain without a clear cause. The study is investigating the effects of a medication called Semaglutide, which is also known by the code name NNC0113-0217, and a very low-calorie diet on body weight and brain pressure in patients with newly diagnosed IIH. The medication is administered as a solution for injection and is available in different doses under the brand names Ozempic and Wegovy.

The purpose of the study is to explore how Semaglutide and dietary changes can help manage weight and reduce brain pressure in individuals with IIH. Participants will receive either the medication or a placebo, along with dietary guidance. The study will last for several months, during which participants will have regular check-ups to monitor changes in their condition, including body weight and brain pressure. The study aims to provide insights into the effectiveness of this combined treatment approach compared to standard management by a dietician.

Throughout the study, participants will undergo various assessments to track their progress. These assessments will include measuring changes in brain pressure and body weight, as well as evaluating the degree of swelling in the optic nerve, which is known as papilledema. Other evaluations will include visual field tests, imaging of the eye, and assessments of headache frequency and intensity. The study will also monitor the overall quality of life and any side effects experienced by participants. The findings from this study could potentially lead to improved treatment options for individuals with Idiopathic Intracranial Hypertension.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of idiopathic intracranial hypertension and ensuring all inclusion criteria are met.

The assessment will involve a review of medical history, a physical examination, and specific tests to measure intracranial pressure and body weight.

2 medication administration

Participants will receive the medication semaglutide through a subcutaneous injection. The dosage will vary depending on the specific product used: Ozempic (0.25 mg, 0.5 mg, or 1 mg) or Wegovy (1.7 mg or 2.4 mg).

Injections will be administered once a week for the duration of the study.

3 dietary program

Participants will follow a very low-calorie diet as part of the study. This diet is designed to assist with weight loss and will be monitored by a dietician.

Regular consultations with the dietician will be scheduled to ensure adherence to the dietary program and to provide support.

4 follow-up assessments

Follow-up assessments will occur at 8 weeks and 10 months to evaluate changes in intracranial pressure and body weight.

Additional evaluations will include eye examinations, headache assessments, and quality of life questionnaires.

5 final evaluation

At the end of the study period, a final evaluation will be conducted to assess the overall impact of the treatment on intracranial pressure, body weight, and other health parameters.

Participants will be informed of the study results and any further recommendations for their health management.

Who Can Join the Study?

Have a new diagnosis of Idiopathic Intracranial Hypertension with swelling of the optic nerve (called papilledema) and a lumbar opening pressure of 25 cm or more of cerebrospinal fluid.
Be a female aged between 18 and 65 years.
Have a Body Mass Index (BMI) of 27 or higher. BMI is a measure of body fat based on height and weight.
Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Currently use or agree to start using contraceptive methods with a failure rate of less than 1% during the study if you are in group A. This includes using methods like hormonal contraceptives (such as pills, patches, vaginal rings, or injections), intrauterine devices (IUDs), having a partner who is permanently sterilized, or practicing credible sexual abstinence for religious or cultural reasons. This should continue for at least 2 months after stopping the study medication, Semaglutide.

Who Cannot Join the Study?

Patients who are not female cannot participate in the study.
Patients who are not within the specified age range cannot participate in the study.
Patients with conditions other than Idiopathic Intracranial Hypertension cannot participate in the study.
Patients who are part of a vulnerable population cannot participate in the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	05.09.2022

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication that helps with weight loss by mimicking a hormone in your body that regulates appetite. It makes you feel full, so you eat less and lose weight. In this trial, it is being used to help reduce body weight and lower pressure inside the skull in patients with a condition called idiopathic intracranial hypertension.

Investigated diseases:

Idiopathic intracranial hypertension

Idiopathic Intracranial Hypertension – Idiopathic Intracranial Hypertension is a condition characterized by increased pressure around the brain without a detectable cause. It often presents with symptoms such as headaches, vision problems, and ringing in the ears. The condition is more common in women, particularly those who are overweight. As the disease progresses, it can lead to swelling of the optic nerve, known as papilledema, which may cause visual disturbances. The increased pressure can also result in frequent headaches and other neurological symptoms. Over time, if not managed, it can lead to persistent vision problems.

Trial ID:

2024-517120-19-02

NCT ID:

NCT06027567

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Semaglutide and Low-Calorie Diet for Weight Loss in Patients with New-Onset Idiopathic Intracranial Hypertension

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