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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week open label 22 (ol22) to week randomized withdraw 12 (rw12)

Awards & highlights

GRACE Trial Summary

This trial is testing a new medication to see if it's effective, safe, and has the same blood levels in people with Cushing syndrome who also have diabetes and/or high 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.Check my eligibility

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.See study design

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.

GRACE Trial 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.

GRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ open label week 22 (ol22) to randomized withdraw week 12 (rw12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~open label week 22 (ol22) to randomized withdraw week 12 (rw12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and open label week 22 (ol22) to randomized withdraw week 12 (rw12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

In all patients, assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.

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

Secondary outcome measures

For patients in either subgroup (DM/IGT or hypertension) the proportion of patients with any increase or modification in diabetes or antihypertensive medication as compared between relacorilant and placebo

In patients with DM (HbA1c at Baseline >6.5%), the mean change from Visit OL22 to RW12 in HbA1c as compared between relacorilant and placebo.

In patients with DM (HbA1c ≥6.5% at Baseline), the mean change in HbA1c from Baseline to Visit OL22/ET

+8 more

GRACE 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 1

~140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor

68 Previous Clinical Trials

6,228 Total Patients Enrolled

12 Trials studying Cushing Syndrome

1,408 Patients Enrolled for Cushing Syndrome

Andreas Moraitis, MDStudy DirectorCorcept Therapeutics

1 Previous Clinical Trials

130 Total Patients Enrolled

1 Trials studying Cushing Syndrome

130 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 25 welcome in this trial?

"The age range for patients that this trial is recruiting are individuals who are over 18 and less than 80 years old."

Answered by AI

Has the Federal Drug Administration sanctioned Relacorilant?

"Relacorilant's safety is reinforced by the fact that this is a Phase 3 trial, which means there is already some data to support its efficacy and multiple rounds of data that suggest it is safe."

Answered by AI

Could you pre-screen me to see if I am eligible for this clinical trial?

"The prerequisites for this medical experiment are a diagnosis of cushing syndrome and being between 18-80 years old. In total, the study will enroll 130 individuals."

Answered by AI

How many research participants are being recruited for this investigation?

"Corcept Therapeutics needs to recruit 130 individuals that meet the study's pre-requisites in order to begin. The sponsor will be managing the trial from several sites, for example Site 51 situated in Dallas, Texas and Site 2 located in Metairie, Louisiana."

Answered by AI

Is the use of Relacorilant an accepted medical practice?

"There are currently 6 clinical trials studying Relacorilant. 2 of these studies have progressed to Phase 3 testing. Additionally, while some of the trial locations for Relacorilant are in Bucuresti and Oklahoma, there are a total of 215 sites running these sorts of tests."

Answered by AI

Are there multiple facilities administering this research in the city?

"There are a total of 28 enrolment sites for this trial. They are situated in Dallas, Metairie, Vancouver and 25 other cities. Researchers recommend that potential participants select the clinical site closest to them to reduce travel time and costs."

Answered by AI