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Silibinin

Silibinin is being studied in clinical trials for people with active Cushing’s disease. These studies look at whether treatment can lower or normalize excess cortisol and how safe and effective it is. The main focus is on adults with this hormone disorder.

Table of contents

Trial overview

This article describes one clinical trial of Silibinin in people with active Cushing’s disease.[1] The study is called Silycus®-21 and is designed to assess both efficacy and safety.[1]

The trial is a multicenter study, which means it is being carried out at more than one study site.[1] It is also an interventional study, meaning participants receive the study treatment and are followed for specific outcomes.[1]

Who can participate

The target population is patients with active Cushing’s disease.[1] The provided data do not list extra inclusion or exclusion rules, so the main known eligibility point is the diagnosis itself.[1]

The brief summary says the study aims to help patients with excess cortisol secretion, so the trial is focused on people whose disease is still active rather than in remission.[1]

Study design and phase

This is a Phase 2 study.[1] Phase 2 trials are usually done after early testing and are meant to see whether a treatment may work in a small group while continuing to watch for safety.[1]

The study is single arm and open label.[1] Single arm means there is no separate comparison group, and open label means everyone knows the treatment being given.[1]

The design also includes dose titration, which means the study can adjust the dose during the trial to find the best treatment amount for the participants.[1]

The intervention listed is Silycus® given by mouth.[1] The source data name the trial substance as Silycus®, while the article title and trial focus use Silibinin.[1]

What is being measured

The main goal is to see whether treatment can lower or normalize excess cortisol secretion.[1] Cortisol is a hormone, and in Cushing’s disease it is often too high.[1]

The trial measures 24-hour urinary free cortisol, late-night salivary cortisol, and response to low-dose dexamethasone.[1] These are standard ways to check whether cortisol control is improving.[1]

The composite endpoint has several parts.[1] It includes the percentage of patients whose UFC becomes normal or drops by at least 50% from before treatment, the percentage of patients with high late-night salivary cortisol at baseline whose saliva cortisol becomes normal, and the percentage of patients who did not suppress after low-dose dexamethasone at baseline but later show normal suppression.[1]

The study plans to assess efficacy after 12 weeks of treatment.[1]

What the study wants to find out

This is a proof of concept study.[1] That means it is an early test to see whether the treatment idea looks promising before larger studies are done.[1]

The study wants to find out whether Silibinin can help reduce excess cortisol secretion in patients with active Cushing’s disease.[1] The main question is not only whether cortisol numbers improve, but also whether the improvement is large enough to matter in a clinical study setting.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 15 participants, which shows that this is a small early-stage study.[1]

Because the trial is small and focused on one group of patients, its results are meant to give early evidence about whether further research is worthwhile.[1]

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

FAQ

  • What are clinical trials with Silibinin studying? They are studying whether Silibinin can reduce or normalize high cortisol levels in people with active Cushing’s disease. The trial also looks at safety and early signs of benefit.
  • Who may take part in these studies? The trial is for patients with active Cushing’s disease. The study summary does not list more detailed entry rules in the provided data.
  • What phase is the Silibinin trial? The trial is in Phase 2. This means it is testing whether the treatment may work and continuing to check safety in a small group of patients.
  • What outcomes are being measured? The study measures 24-hour urinary free cortisol, late-night salivary cortisol, and response to low-dose dexamethasone. These tests help show whether cortisol levels improve.
  • How many people are planned for the study? The trial plans to include 15 participants. This is a small proof-of-concept study, which means it is an early study to see if the approach looks promising.

Igangværende kliniske forsøg for Silibinin

  • Undersøgelse af naturmedicinen silymarin til behandling af for højt cortisol hos patienter med Cushings sygdom

    Rekrutterer ikke

    1 1
    Undersøgte lægemidler:
    Italien

Ordliste

  • Cushing’s disease: A condition where the body makes too much cortisol because of a problem in the hormone control system. It can cause many health problems and needs careful testing.
  • Cortisol: A hormone made by the body that helps with stress and many body functions. Too much cortisol can be harmful.
  • Active disease: This means the condition is currently causing symptoms or abnormal test results, not in remission.
  • Phase 2: A mid-stage clinical trial that checks whether a treatment may work and continues to look at safety in a small group.
  • Open label: A study design where both the patient and the study team know which treatment is being given.
  • Single arm: A study with only one treatment group. There is no comparison group receiving another treatment or placebo.
  • Dose titration: A planned adjustment of the dose during the study to find the best amount for the patient.
  • Proof of concept: An early study done to see whether a treatment idea seems to work before larger studies are done.
  • Urinary free cortisol (UFC): A urine test that measures cortisol over 24 hours. It helps show how much cortisol the body is making.
  • Late-night salivary cortisol: A saliva test taken late at night to check cortisol levels at a time when they should normally be low.
  • Low-dose dexamethasone suppression test: A test that checks whether the body can lower cortisol after taking a small dose of dexamethasone. Poor suppression can be a sign of Cushing’s disease.

Referencer

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