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Silibinin

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.

Table of contents

Trial overview

The available trial is studying Silibinin in people with Cushing’s disease, a condition linked to excess cortisol.[1] The study is designed to see whether treatment can decrease or normalize cortisol levels in patients with active disease.[1]

This is an interventional study, which means researchers give the study treatment and then measure the results.[1] The brief summary says the goal is to evaluate efficacy, which means how well the treatment works, along with safety in this patient group.[1]

Who is being studied

The target population is patients with active Cushing’s disease.[1] The trial data do not list more detailed inclusion or exclusion rules, so the available information only confirms the disease group being studied.[1]

The study is focused on a small, specific group rather than a broad patient population.[1] 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.[1]

Study design and phase

The trial is Phase 2, which means it is in an intermediate stage of testing.[1] 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.[1]

The study is described as single arm and open label.[1] 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.[1]

It is also a dose titration and proof of concept study.[1] 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.[1]

What is being measured

The main outcome is efficacy, assessed after 12 weeks of administration.[1] Researchers will look at several tests that measure cortisol control in different ways.[1]

  • 24-hour urinary free cortisol (UFC): a full-day urine test that shows how much cortisol leaves the body.[1]
  • Late-night salivary cortisol: a saliva test taken at night, when cortisol should normally be low.[1]
  • Low-dose dexamethasone suppression: a test that checks whether cortisol levels drop as expected after a small dose of dexamethasone.[1]

The trial uses a composite endpoint, which means several results are combined to judge success.[1] 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.[1]

Trial status and size

The trial status is Authorised, meaning it has been approved to move forward.[1] The planned enrollment is 15 patients, so this is a small study.[1]

The study title identifies the trial as Silycus®-21 and describes it as a multicenter study.[1] Multicenter means more than one study site is involved, which can help recruit patients and collect results from different locations.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518869-99-00 Phase 2 Cushing’s disease Authorised 15

FAQ

  • What is being studied in Silibinin clinical trials? The trial is studying whether Silibinin can reduce or normalize excess cortisol in people with active Cushing’s disease. It measures this with urine, saliva, and dexamethasone testing.
  • Who can take part in the trial? The study is for patients with active Cushing’s disease. The trial data do not give more detailed eligibility rules.
  • What phase is the Silibinin trial? The trial is a Phase 2 study. This means it is looking more closely at whether the treatment works and how safe it is in a small group.
  • How many people are planned for the study? The planned enrollment is 15 patients. This is a small, focused study.
  • What results are the researchers measuring? Researchers are looking at 24-hour urinary free cortisol, late-night salivary cortisol, and response to low-dose dexamethasone. They will check how many patients normalize or improve after 12 weeks.

Ongoing Clinical Trials on Silibinin

  • Study on the Effectiveness and Safety of Silibinin for Patients with Active Cushing’s Disease

    Not recruiting

    1 1
    Investigated drugs:
    Italy

Glossary

  • Cushing’s disease: A condition where the body has too much cortisol, a hormone that helps control stress, sugar use, and many body functions.
  • Cortisol: A hormone made by the body. Too much cortisol can cause health problems, which is why the trial measures it.
  • Active disease: The illness is currently causing signs or abnormal test results, not just a past history of the condition.
  • Phase 2: A trial stage that looks at whether a treatment may work and continues to monitor safety in a small group of patients.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Open label: Both the researchers and the patients know which treatment is being given.
  • Single arm: A study with only one treatment group and no comparison group.
  • Dose titration: A method where the treatment dose may be adjusted during the study.
  • Proof of concept: An early study designed to see if a treatment shows signs that it may work.
  • 24-hour urinary free cortisol (UFC): A urine test that measures how much cortisol leaves the body in a full day.
  • Late night salivary cortisol: A saliva test taken late at night to check cortisol levels when they should normally be low.
  • Low dose dexamethasone suppression test: A test that checks whether the body lowers cortisol after a small dose of dexamethasone, a steroid medicine used for testing.

References

  1. https://clinicaltrials.gov/study/2024-518869-99-00