Long-Term Use of Relacorilant for Cushing Syndrome

Recruiting at 78 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Corcept Therapeutics

Must be taking: Relacorilant

Disqualifiers: Hypothyroidism, Hyperthyroidism, Hypertension, Renal failure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Relacorilant for Cushing Syndrome?

Research shows that Relacorilant, a drug that blocks certain stress hormone receptors, has been effective in improving symptoms in patients with Cushing Syndrome, such as controlling high blood pressure and blood sugar levels, with a good safety profile. ^{1 2 3 4 5}

Is relacorilant safe for long-term use in humans?

Relacorilant has been studied for safety in patients with Cushing syndrome, and it does not cause prolongation of the heart's QT interval (a measure of heart rhythm). It is a selective glucocorticoid receptor modulator, meaning it targets specific receptors without affecting others, which may reduce side effects. ^{1 4 5 6 7}

How is the drug Relacorilant unique in treating Cushing Syndrome?

Relacorilant is unique because it is a selective glucocorticoid receptor modulator, meaning it specifically targets and modulates the glucocorticoid receptor without affecting the progesterone receptor, which helps avoid certain side effects seen with other treatments. This selectivity may offer a better safety profile, particularly in avoiding heart-related side effects and issues related to glucose metabolism. ^{1 2 4 5 8}

Research Team

Katherine Araque, MD, MSCR

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

This trial is for patients with Cushing Syndrome who have finished a previous Corcept-sponsored relacorilant study and took their medication at least 80% of the time. They should not have dropped out early, nor should they have uncontrolled thyroid issues, poorly controlled high blood pressure, or severe kidney failure.

Inclusion Criteria

You have participated in a previous study on relacorilant for Cushing syndrome and followed the dosing schedule at least 80% of the time.

The doctor believes it is beneficial for you to keep taking relacorilant.

Exclusion Criteria

My thyroid condition is not under control.

My high blood pressure is not well-managed.

My kidney function is severely reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants continue therapy with relacorilant for long-term safety evaluation

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Relacorilant

Trial Overview The trial is testing the long-term safety of a drug called relacorilant in those with endogenous Cushing Syndrome. It's an open-label extension which means everyone knows they are getting relacorilant and there's no placebo group.

Participant Groups

Group I: relacorilant (CORT125134) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Findings from Research

Pasireotide, both in its twice-daily subcutaneous and once-monthly intramuscular formulations, has shown effective treatment outcomes for Cushing's disease in clinical trials, with a generally good safety profile, although it can cause hyperglycemia that requires monitoring.

Osilodrostat, a novel agent, has demonstrated rapid and sustained control of Cushing's disease in recent clinical trials, indicating its potential as an effective treatment option alongside other investigational drugs like levoketoconazole and mifepristone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Treatment of Cushing's Disease: An Overview of the Current and Recent Clinical Trials. Pivonello, R., Ferrigno, R., De Martino, MC., et al.[2021]

Endogenous Cushing's syndrome is a serious condition that can lead to increased health risks if not treated properly, and medical treatments are essential for managing cortisol levels, especially after surgery or while awaiting radiation therapy.

Recent advancements in medical treatments include new steroidogenesis inhibitors, pituitary-directed drugs, and glucocorticoid receptor antagonists, which may offer fewer side effects and target the underlying causes of Cushing's syndrome more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Management of Cushing's Syndrome: Current and Emerging Treatments. Hinojosa-Amaya, JM., Cuevas-Ramos, D., Fleseriu, M.[2020]

Recent advancements in medical therapies for Cushing's syndrome include drugs that target dopamine and somatostatin receptors, which can control cortisol production in up to 40% of patients, providing a viable option when surgery is not successful.

New drug candidates like osilodrostat, levoketoconazole, and CORT125134 are being evaluated in multicenter trials, offering hope for more effective and personalized treatments for Cushing's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the medical treatment of Cushing's syndrome. Feelders, RA., Newell-Price, J., Pivonello, R., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Relacorilant, a Selective Glucocorticoid Receptor Modulator, Induces Clinical Improvements in Patients With Cushing Syndrome: Results From A Prospective, Open-Label Phase 2 Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Medical Treatment of Cushing's Disease: An Overview of the Current and Recent Clinical Trials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Peripheral glucocorticoid receptor antagonism by relacorilant with modest HPA axis disinhibition. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Relacorilant, a Selective Glucocorticoid Receptor Modulator in Development for the Treatment of Patients With Cushing Syndrome, Does Not Cause Prolongation of the Cardiac QT Interval. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Medical Management of Cushing's Syndrome: Current and Emerging Treatments. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Advances in the medical treatment of Cushing's syndrome. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Glucocorticoid receptor blockers. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[The medical management of Cushing's syndrome]. [2018]