What side effects are associated with this type of intervention?

Common treatments for Cushing Syndrome, including glucocorticoid receptor antagonists like Relacorilant, can have several side effects. These may include hyperglycemia, increased susceptibility to infections, bone loss, fractures, and neuropsychiatric effects such as mood swings or insomnia. Systemic glucocorticoids, another treatment option, are associated with significant adverse effects like growth retardation in children, Cushingoid appearance, elevated blood pressure, hyperglycemia, cataracts, and osteoporosis. Steroid-sparing agents like methotrexate can also have side effects, though they are generally fewer compared to systemic glucocorticoids.

What prior FDA approvals exist?

The FDA has approved several treatments for Cushing Syndrome, including medications that target the underlying causes of the condition. One notable drug is Mifepristone (Korlym), which, like Relacorilant, is a Glucocorticoid Receptor Antagonist. Mifepristone is used to control hyperglycemia secondary to hypercortisolism in patients with endogenous Cushing Syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Other treatments include Ketoconazole and Mitotane, which inhibit cortisol synthesis, and Pasireotide, a somatostatin analog that reduces ACTH production. These treatments aim to manage the symptoms and biochemical abnormalities associated with Cushing Syndrome.

What other types of research exist?

Promising novel alternatives to Relacorilant for Cushing Syndrome patients include Osilodrostat, a steroidogenesis inhibitor that has shown efficacy in reducing cortisol levels, and Levoketoconazole, another steroidogenesis inhibitor that has been effective in managing hypercortisolism. Both have been evaluated in recent clinical trials and offer new options for patients with Cushing Syndrome.

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Corticosteroid

Relacorilant for Cushing Syndrome (GRACE Trial)

Phase 3

Waitlist Available

Research Sponsored by Corcept Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a confirmed diagnosis of endogenous Cushing syndrome

Has impaired glucose tolerance

Must not have

Has severe renal insufficiency

Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week ol22 to week rw12

Awards & highlights

Pivotal Trial

Summary

This trial tests relacorilant, a daily pill, in people with Cushing syndrome who also have diabetes or high blood pressure. The medication aims to block excess cortisol to help manage their blood sugar and blood pressure.

Who is the study for?

This trial is for people with endogenous Cushing syndrome, often having type 2 diabetes or uncontrolled high blood pressure. Participants must have a confirmed diagnosis and cannot join if they have non-endogenous hypercortisolemia, thyroid issues not under control, severe kidney problems, or poorly managed hypertension or diabetes.

What is being tested?

The study tests the effectiveness and safety of Relacorilant compared to a placebo in managing Cushing syndrome symptoms. It's a Phase 3 trial where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.

What are the potential side effects?

Possible side effects of Relacorilant may include changes in blood sugar levels, blood pressure alterations, and potential impacts on organ functions due to hormone level fluctuations that the medication aims to manage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with endogenous Cushing syndrome.

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My blood sugar levels are higher than normal but not high enough to be diabetes.

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I have Type 2 diabetes.

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I have high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney problems.

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My thyroid condition is not under control.

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My high cortisol levels are not caused by my body's own production.

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My high blood pressure is not well-managed.

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My diabetes is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week ol22 to week rw12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week ol22 to week rw12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week ol22 to week rw12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

In patients with hypertension, the proportion of patients with a loss of response with respect to hypertension from visit OL22 to RW12

Secondary study objectives

In patients with uncontrolled hypertension the mean change in SBP or DBP from Baseline to visit OL22/ET

Proportion of patients who worsened, as assessed by the Global Clinical Response, from Week OL22 to Week RW12/ET as compared between relacorilant and placebo

The mean change in body weight, body fat measured with DXA scan and Cushing Quality-of-Life (QoL) score as compared between relacorilant and placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Relacorilant (randomized-withdrawal phase)Experimental Treatment1 Intervention

Patients who meet any of the response criteria will advance to the randomized-withdrawal phase of the study and receive the same highest dose as in the open-label phase.

Group II: Relacorilant (open-label phase)Experimental Treatment1 Intervention

The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.

Group III: Placebo (randomized-withdrawal phase)Placebo Group1 Intervention

Placebo matched to study drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relacorilant

2021

Completed Phase 3

~290

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cushing Syndrome is commonly treated with medications that either reduce cortisol production or block its effects. Glucocorticoid receptor antagonists, such as Relacorilant, work by blocking the effects of cortisol at its receptor sites, thereby mitigating the symptoms caused by excess cortisol. This is crucial for patients as it helps manage hyperglycemia, hypertension, and other metabolic disturbances associated with the syndrome. Other treatments include steroidogenesis inhibitors, which reduce cortisol synthesis, and somatostatin analogs, which inhibit ACTH secretion. These treatments are essential for controlling the disease and improving the quality of life for patients with Cushing Syndrome.