A Trial of Lu AG13909 in Adult Participants With Cushing's Disease

To join this study, you must be an adult aged between 18 and 70 years old and have a confirmed diagnosis of Cushing's disease. This means your high cortisol levels are caused by a problem with your pituitary gland, a small gland in your brain. Doctors would have confirmed this using tests like an MRI scan of your brain, or other specific blood tests.

Your 24-hour urine test results should show that your cortisol levels are still quite high despite any current treatments. While you might have other health conditions like diabetes or high blood pressure, these need to be well-managed. If you are currently taking other medicines for Cushing's disease, you might need to stop them for a short time before starting this study.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or planning to get pregnant, you cannot take part. If you have severe and uncontrolled health issues, a known allergy to the study medicine, or if your doctor believes you need surgery for your pituitary gland very soon, you would also not be able to participate. The medical team will check all these carefully to make sure the study is safe for you.

If you join this study, you will go through different periods where you will receive the study medicine, Lu AG13909. Initially, the medicine might be given through a drip into your arm (intravenously), and then later, it may be given as an injection under your skin (subcutaneously). The dose of the medicine may be adjusted during these periods to find what works best for you. During the study, you will have regular visits to the clinic. These visits will involve various tests, such as blood tests (to check cortisol levels and overall health), urine tests, physical examinations, and heart rhythm checks (ECGs). These assessments help us monitor how you are responding to the medicine and ensure your safety.

After these initial treatment periods, there will be a longer `Maintenance Period` where you will continue to receive the medicine, followed by an `Extension Period` if you and your doctor agree. Throughout the entire study and after finishing the medicine, there will be `Safety Follow-up Periods` to check on your long-term health. The total duration of your participation could range from several months to potentially longer, depending on which parts of the study you participate in.