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Dual action weight loss in IIH - IIHDUAL
EU CTIS ID: 2024-517120-19-02
What this study is testing
To investigate the effect of Semaglutide and a Very Low Calorie Diet on body weight and intracranial pressure in patients with new-onset idiopathic intracranial hypertension compared to standard management (dietician)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- New-onest definite idiopathic intracranial hypertension with papilledema and lumbar opening pressure >= 25 cm cerebrospinal fluid
- Female aged 18-65 years
- BMI >= 27
- Written informed consent
- Current use or consent to initiate the use of contraceptive methods with failure rates of less than 1 % throughout the study period if randomized to group A including at least an additional 2 months after cessation of Semaglutide® (including hormonal contraceptives (oral, transdermal, vaginal ring, injections), intrauterine devices (hormonal or copper), permanent sterilized partner or credible sexual abstinence e.g. for religious or cultural reasons.
You likely can't join if
- Unable to provide written informed consent or participate
- Malignant IIH with visual threat that requires VP-shunting, optic nerve sheet fenestration or other surgical CSF diversion
- Pregnancy or breastfeeding
- Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
- Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g., retinopathy)
- History or family history of thyroid carcinomas or other MEN1/MEN2 carcinomas
See the full eligibility criteria
- New-onest definite idiopathic intracranial hypertension with papilledema and lumbar opening pressure >= 25 cm cerebrospinal fluid
- Female aged 18-65 years
- BMI >= 27
- Written informed consent
- Current use or consent to initiate the use of contraceptive methods with failure rates of less than 1 % throughout the study period if randomized to group A including at least an additional 2 months after cessation of Semaglutide® (including hormonal contraceptives (oral, transdermal, vaginal ring, injections), intrauterine devices (hormonal or copper), permanent sterilized partner or credible sexual abstinence e.g. for religious or cultural reasons.
- Unable to provide written informed consent or participate
- Malignant IIH with visual threat that requires VP-shunting, optic nerve sheet fenestration or other surgical CSF diversion
- Pregnancy or breastfeeding
- Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
- Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g., retinopathy)
- History or family history of thyroid carcinomas or other MEN1/MEN2 carcinomas
- History of bariatric surgery
- Known hypersensitivity to any contents of Semaglutide®
- Other severe/uncontrolled mental or physical disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.