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Study on the Long-Term Safety of Relacorilant for Patients with Cushing Syndrome

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for Endogenous Cushing Syndrome, a condition where the body produces too much of the hormone cortisol. The treatment being studied is a medication called relacorilant, also known by its code name CORT125134. This study is an extension of previous research to further understand how safe relacorilant is for patients with this condition.

The purpose of the study is to monitor the safety of relacorilant over an extended period. Participants in the study will continue to receive relacorilant and will be regularly assessed for any side effects or changes in their health. This includes checking for any new or worsening symptoms, as well as conducting routine health checks such as blood tests, physical exams, and heart monitoring using electrocardiograms (ECGs). For those with a specific type of Cushing Syndrome caused by a pituitary tumor, magnetic resonance imaging (MRI) scans will be used to observe any changes in the tumor.

Throughout the study, participants will have regular visits to the study site to ensure their well-being and to gather important information about the effects of relacorilant. The study aims to provide valuable insights into the long-term use of relacorilant for managing the symptoms of Endogenous Cushing Syndrome, helping to improve treatment options for those affected by this condition.

1 joining the study

Upon joining the study, ensure that written informed consent is provided. This confirms understanding and agreement to participate in the study.

If applicable, ensure the use of a highly effective method of contraception starting 30 days before entering the study and continuing until 28 days after the last dose of the study drug.

2 initial assessments

Attend the investigative site for initial evaluations. These may include clinical laboratory tests, physical examinations, and vital sign measurements.

For those with Cushing syndrome due to a pituitary tumor, obtain a pituitary MRI or CT scan to assess changes in tumor size. This can be done up to 6 months before starting treatment or up to 6 weeks after starting treatment.

3 medication administration

Begin taking the study drug, relacorilant, as prescribed by the study team. The dosage and frequency will be determined by the study protocol and communicated by the healthcare provider.

4 ongoing monitoring

Attend monthly visits to the investigative site for monitoring. This includes assessments for any treatment-emergent adverse events, changes in laboratory tests, physical examinations, and vital sign measurements.

Undergo regular electrocardiograms (ECGs) to monitor heart function, including measurements of the QTcF interval, QRS complex, PR interval, and heart rate.

5 end of study procedures

Upon completion of the study, final evaluations will be conducted. These may include laboratory tests, physical examinations, and imaging studies to assess the overall impact of the treatment.

Ensure that any required follow-up actions, such as continued use of contraception, are completed as instructed by the study team.

Who Can Join the Study?

  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome.
  • According to the doctor’s opinion, will benefit from treatment with relacorilant.
  • Provide written informed consent, which means you agree to participate after understanding the study details.
  • If you are a female who can have children, you must be willing to use a highly effective method of birth control from 30 days before starting the study until 28 days after the last dose of the study drug. Male participants with a female partner must agree to use 2 forms of birth control, one of which must be a double-barrier method, from study entry until 28 days after the last dose of the study drug.
  • Are willing to avoid using drugs that affect hormone production by the adrenal glands or hormone release by a tumor.
  • Are able to return to the study site to complete the required evaluations.
  • If you have Cushing syndrome due to a tumor in the pituitary gland, you must be able to have an MRI scan of the pituitary gland (up to 6 months before starting treatment in this study, or up to 6 weeks after starting treatment in this study) to check for changes in tumor size. A CT scan can be used instead if an MRI is not suitable for you.
  • If you are entering the study more than 12 weeks after completing the last dose in the previous study, confirmation of high cortisol levels consistent with the criteria of the previous study is required.
  • If you received treatment for high cortisol levels after your last dose in the previous study, confirmation of high cortisol levels consistent with the criteria of the previous study is required.

Who Cannot Join the Study?

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who have had major surgery within the last 30 days.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of certain heart conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
National Institute Of Endocrinology C.I. Parhon Bucharest Romania
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Politecnica Delle Marche Ancona Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Pxnhxsi Munfbz Sms z Ophn Esv Pbzznvngg Poniatowa Poland
Enkcsfe Uoreeonvzzkq Mkuhkni Cjvgoxr Rpskcpusk (qkjyvll Msr Rotterdam The Netherlands
Kmcokrrf drn Utincfoclspi Mkrwzfud Aug Munich Germany
Uynecxrcaepmhmkugalnp Wahygtjcw Aex Wuerzburg Germany
Uvzaeozqrv Dmhwp Sxbcy Dv Rpos Ls Soiwbedz Rome Italy
Mhimmdp Cwejrf Altya Iup Pfznxgs Ejuf Sofia Bulgaria
Ienab Opgpuqhr Abkorupjjk Spj Liqm Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
07.05.2018
Bulgaria Bulgaria
Not recruiting
07.05.2018
Germany Germany
Not recruiting
07.05.2018
Italy Italy
Not recruiting
07.05.2018
Poland Poland
Not recruiting
07.05.2018
Romania Romania
Not recruiting
07.05.2018
Spain Spain
Not recruiting
07.05.2018
The Netherlands The Netherlands
Not recruiting
07.05.2018

Trial locations

Relacorilant is a medication being studied for its potential to help people with a condition called endogenous Cushing syndrome. This condition happens when the body produces too much of a hormone called cortisol, which can lead to various health problems. Relacorilant works by blocking the effects of cortisol, which may help reduce the symptoms and signs of this syndrome. The clinical trial is focused on understanding how safe it is to use relacorilant over a long period for treating this condition.

Endogenous Cushing Syndrome – This disease is characterized by the overproduction of cortisol by the adrenal glands, often due to a pituitary tumor that secretes excess adrenocorticotropic hormone (ACTH). The progression of the disease involves a range of symptoms such as weight gain, particularly around the abdomen and face, thinning skin, and easy bruising. Muscle weakness and fatigue are common as the condition advances. Patients may also experience high blood pressure and changes in mood or mental health. Over time, the excess cortisol can lead to complications like osteoporosis and type 2 diabetes. The disease requires careful monitoring to manage its symptoms and prevent further complications.

Trial ID:
2024-514079-17-00
Protocol code:
CORT125134-452
Trial Phase:
Therapeutic use (Phase IV)

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