Ongoing Clinical Trials for Cushing’s Syndrome
There are currently 3 clinical trials investigating new treatments and diagnostic methods for Cushing’s syndrome. These studies are testing medications and advanced imaging techniques to help manage symptoms and improve diagnosis of this hormonal disorder caused by excess cortisol production.
Clinical trial locations
- Austria
- Bulgaria
- Germany
- Greece
- Italy
- Netherlands
- Poland
- Romania
- Spain
Study on Fluasterone for Managing High Blood Sugar in Adults with Cushing’s Syndrome
This trial is testing a new medication called Fluasterone Buccal Tablet for adults who have high blood sugar levels caused by Cushing’s syndrome. The medication is designed to dissolve in the mouth when placed against the inside of the cheek, allowing it to enter the bloodstream directly.
Who can participate:
- Adults between 18 and 75 years old
- People who have been evaluated for Cushing syndrome within the last 12 months and meet specific criteria based on cortisol levels in urine, blood, or saliva tests
- Individuals diagnosed with impaired glucose tolerance or type 2 diabetes
- If taking medication for high blood sugar, the dose must have been stable for at least 60 days
- Those who had surgery for the condition and took cortisol replacement medication must have stopped it for at least one week before screening
Who cannot participate:
- People not diagnosed with the syndrome
- Those without impaired glucose tolerance or diabetes
- Individuals outside the specified age range
What the study involves: This is a 12-week study with a crossover design, meaning participants will receive both the actual medication and a placebo at different times. Neither participants nor researchers will know which treatment is being given at any point. The study includes regular blood sugar monitoring through oral glucose tolerance tests at weeks 6 and 12, along with assessments of other health indicators to ensure safety.
Study goal: To determine whether Fluasterone Buccal Tablet can effectively control high blood sugar levels in adults with this condition and to evaluate its safety profile.
Study on Using [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Patients with Cushing’s Disease
This study is evaluating a special imaging technique called [18F]FET PET-MRI to help doctors better detect small tumors in the pituitary gland that cause Cushing’s disease. This advanced imaging combines two technologies: PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging).
Who can participate:
- Adults aged 18 years and older
- People with confirmed ACTH-dependent hypercortisolism, which means high levels of the hormone ACTH in the blood and at least two positive tests showing elevated cortisol
- Those with a small pituitary growth (less than 10mm) or unclear results from standard MRI scans
- Individuals who need further evaluation with a procedure called IPSS (Inferior Petrosal Sinus Sampling)
Who cannot participate:
- Those without ACTH-dependent hypercortisolism
- People outside the specified age range
- Vulnerable populations at higher risk of harm
What the study involves: Participants will receive an injection of a radioactive substance called [18F]FET through a vein in the arm, followed by the PET-MRI scan. The imaging helps create detailed pictures of the pituitary gland to locate tumors. After the scan, follow-up appointments will discuss the results and compare them with standard IPSS procedures.
Study goal: To determine if [18F]FET PET-MRI can more accurately identify pituitary adenomas causing Cushing’s disease compared to current standard methods, and to help distinguish between Cushing’s disease and ectopic Cushing’s syndrome, where excess cortisol comes from tumors outside the pituitary gland.
Study on the Long-Term Safety of Relacorilant for Patients with Cushing Syndrome
This is an extension study looking at the long-term safety of relacorilant (also known as CORT125134), a medication that blocks the effects of cortisol in the body. This trial is for people who have already participated in a previous study of this medication.
Who can participate:
- People who completed a previous Corcept-sponsored study of relacorilant for endogenous Cushing syndrome
- Those who, according to their doctor, will benefit from continued treatment with relacorilant
- Individuals able to return to the study site for required evaluations
- Women of childbearing age must use highly effective birth control from 30 days before the study until 28 days after the last dose
- For those with pituitary tumors, an MRI or CT scan of the pituitary gland must be obtainable
- If more than 12 weeks have passed since the last dose in the previous study, or if other treatments were received, confirmation of high cortisol levels is required
Who cannot participate:
- Pregnant or breastfeeding women
- People who participated in another clinical trial within the last 30 days
- Those with known allergies to the medication or its ingredients
- Individuals unable to follow study procedures or attend required visits
- People with a history of drug or alcohol abuse within the past year
- Those who had major surgery within the last 30 days
- Individuals with uncontrolled high blood pressure, severe liver or kidney disease, or certain heart conditions
What the study involves: Participants will continue taking relacorilant tablets as prescribed and attend monthly visits to the study site. These visits include monitoring for side effects, blood tests, physical examinations, vital sign measurements, and electrocardiograms (ECGs) to check heart function. For those with pituitary tumors, imaging studies will assess any changes in tumor size.
Study goal: To monitor the long-term safety of relacorilant in managing symptoms of endogenous Cushing syndrome and to gather important information about the effects of extended use of this medication.
Summary
Three clinical trials are currently recruiting patients with Cushing’s syndrome across Europe. These studies represent different approaches to managing this hormonal disorder caused by excess cortisol production.
The trials span multiple countries, with the relacorilant safety study having the broadest geographical reach across eight European nations including Italy, Bulgaria, Romania, Spain, Austria, Poland, Germany, and the Netherlands. The other two studies are more geographically focused, with the Fluasterone study taking place in Greece and the advanced imaging study in the Netherlands.
Two of the trials focus on medications that work differently: Fluasterone aims to control high blood sugar levels associated with the condition, while relacorilant blocks the effects of excess cortisol itself. The third study takes a diagnostic approach, testing whether advanced PET-MRI imaging can better identify the small pituitary tumors that often cause the disease.
Notably, the relacorilant study is an extension trial for patients who have already participated in previous research, focusing on long-term safety monitoring. This reflects an important phase in understanding how medications perform over extended periods of use. The Fluasterone study uses a crossover design allowing participants to experience both treatment and placebo, helping to establish clear comparisons.
These trials offer options for patients at different stages: those newly diagnosed who meet specific cortisol and blood sugar criteria, those needing better diagnostic imaging, and those already familiar with investigational treatments who can contribute to long-term safety data.
