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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 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

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.

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
69 Previous Clinical Trials
6,331 Total Patients Enrolled
12 Trials studying Cushing Syndrome
1,415 Patients Enrolled for Cushing Syndrome
Andreas Moraitis, MDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
137 Total Patients Enrolled
1 Trials studying Cushing Syndrome
137 Patients Enrolled for Cushing Syndrome

Media Library

Relacorilant (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03697109 — Phase 3
Cushing Syndrome Research Study Groups: Relacorilant (open-label phase), Relacorilant (randomized-withdrawal phase), Placebo (randomized-withdrawal phase)
Cushing Syndrome Clinical Trial 2023: Relacorilant Highlights & Side Effects. Trial Name: NCT03697109 — Phase 3
Relacorilant (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03697109 — Phase 3
~22 spots leftby Oct 2025
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