In short
Clinical trials are investigating Silibinin in people with Cushing’s disease. The study data focus on whether Silibinin can help lower high cortisol levels and how safe and effective it is in this patient group. The main trial is an early proof-of-concept study in adults with active disease.
Key points
- Clinical trials are studying Silibinin in people with active Cushing’s disease. The main trial is a Phase 2, single-arm, open-label study, which means everyone gets the same treatment and both the team and patients know what is given. Researchers want to see whether Silibinin can lower or normalize excess cortisol after 12 weeks. The study is small, with 15 planned participants. The main outcomes use urine, saliva, and low-dose dexamethasone testing to measure cortisol changes.
Trial overview
The available trial is studying Silibinin in people with Cushing’s disease, a condition linked to excess cortisol. The study is designed to see whether treatment can decrease or normalize cortisol levels in patients with active disease.
This is an interventional study, which means researchers give the study treatment and then measure the results. The brief summary says the goal is to evaluate efficacy, which means how well the treatment works, along with safety in this patient group.
Who is being studied
The target population is patients with active Cushing’s disease. The trial data do not list more detailed inclusion or exclusion rules, so the available information only confirms the disease group being studied.
The study is focused on a small, specific group rather than a broad patient population. This kind of design is common in early studies that try to find out whether a treatment shows a useful signal before larger trials are done.
Study design and phase
The trial is Phase 2, which means it is in an intermediate stage of testing. Phase 2 studies usually look more closely at whether a treatment may work and continue to watch for safety issues in a smaller group of patients.
The study is described as single arm and open label. Single arm means there is only one treatment group, and open label means both the study team and the patients know what treatment is being given.
It is also a dose titration and proof of concept study. Dose titration means the dose may be adjusted during the study, while proof of concept means the trial is trying to show early signs that the treatment may help.
What is being measured
The main outcome is efficacy, assessed after 12 weeks of administration. Researchers will look at several tests that measure cortisol control in different ways.
- 24-hour urinary free cortisol (UFC): a full-day urine test that shows how much cortisol leaves the body.
- Late-night salivary cortisol: a saliva test taken at night, when cortisol should normally be low.
- Low-dose dexamethasone suppression: a test that checks whether cortisol levels drop as expected after a small dose of dexamethasone.
The trial uses a composite endpoint, which means several results are combined to judge success. The study looks for patients whose UFC normalizes or drops by at least 50%, patients with high salivary cortisol at baseline whose levels normalize, and patients who did not suppress normally at baseline but later show normal suppression.
Trial status and size
The trial status is Authorised, meaning it has been approved to move forward. The planned enrollment is 15 patients, so this is a small study.
The study title identifies the trial as Silycus®-21 and describes it as a multicenter study. Multicenter means more than one study site is involved, which can help recruit patients and collect results from different locations.