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
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
Pqdkjub Mgzobt Sae z Obxf Eiy Pkbqppzsm	Poniatowa	Poland
Ecwhocy Unlbnjnsfafj Mlxyozt Cwvjawi Rrbguccsq (vdrqrid Mgk	Rotterdam	The Netherlands
Klaczlsh dcx Uwpcumpbqiyv Muqpvpdy Apu	Munich	Germany
Uqydibnnyhipnqbpjtbfg Wuzrcdkmd Aib	Wuerzburg	Germany
Uvsjulccbk Ddtso Skybu Dt Rnsp Lx Saqpiele	Rome	Italy
Mljztej Cpumli Adymm Ihw Pxuayps Eqpm	Sofia	Bulgaria
Ivuqm Oekznhxr Arqmepzltl Syi Lapn	Milan	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	07.05.2018
Bulgaria	Not recruiting	07.05.2018
Germany	Not recruiting	07.05.2018
Italy	Not recruiting	07.05.2018
Poland	Not recruiting	07.05.2018
Romania	Not recruiting	07.05.2018
Spain	Not recruiting	07.05.2018
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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Study on the Long-Term Safety of Relacorilant for Patients with Cushing Syndrome

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