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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

Short name GRACE

NCTNCT03697109 (opens ClinicalTrials.gov in a new tab)Other idCORT125134-455
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the conditions.

Overview

Status
Completed
Phase
Phase 3
Enrollment
152 participants (actual)
Sponsor
Corcept Therapeutics · Industry
Design
Randomized · Triple masking
Countries
11 countries

United States, Austria, Bulgaria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain

Start
15 Nov 2018
Primary completion
8 Apr 2024
Completion
15 Apr 2024
First posted
5 Oct 2018
Last update posted
16 Jul 2025
Conditions
Cushing Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 3

    GRACE

    NCT03697109

    15 Nov 2018 to 15 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).

Interventions

  • RelacorilantDrug
  • PlaceboOther

Arms3

  • Experimental

    Relacorilant (OL Phase)

    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.

  • Experimental

    Relacorilant (RW Phase)

    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.

  • Placebo comparator

    Placebo (RW Phase)

    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.

    Time frame · Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

    Registry description

    Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.

  2. Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

    Time frame · OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase

Secondary outcomes(6)

  1. Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase

    Time frame · Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

  2. Change in Hemoglobin HbA1c During the RW Phase

    Time frame · Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

  3. Change in 2-hour Plasma Glucose During the RW Phase

    Time frame · Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

    Registry description

    Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).

  4. Change in SBP and DBP During the RW Phase

    Time frame · Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

    Registry description

    Blood pressure was measured by 24-hour ABPM.

  5. Change in Body Weight During the RW Phase

    Time frame · Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

  6. Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase

    Time frame · Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.

GroupValue (Participants)
Relacorilant (RW Phase)3
Placebo (RW Phase)1
Primary outcomeCount of participants· OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase

Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

GroupValue (Participants)
Relacorilant (OL Phase)147
Relacorilant (RW Phase)23
Placebo (RW Phase)27
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase

GroupValue (hours x mmol/L)
Relacorilant (RW Phase)1.91
Placebo (RW Phase)4.81
Secondary outcomeLeast squares mean· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Change in Hemoglobin HbA1c During the RW Phase

GroupValue (Percentage)
Relacorilant (RW Phase)0.06
Placebo (RW Phase)0.28
Secondary outcomeLeast squares mean· Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Change in 2-hour Plasma Glucose During the RW Phase

GroupValue (mmol/L)
Relacorilant (RW Phase)0.52
Placebo (RW Phase)2.96
Secondary outcomeLeast squares mean· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Change in SBP and DBP During the RW Phase

GroupValue (mm Hg)
Relacorilant (RW Phase)3.95
Placebo (RW Phase)10.43
Secondary outcomeLeast squares mean· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Change in Body Weight During the RW Phase

GroupValue (kg)
Relacorilant (RW Phase)-1.21
Placebo (RW Phase)0.54
Secondary outcomeCount of participants· Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)

Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase

GroupValue (Participants)
Relacorilant (RW Phase)1
Placebo (RW Phase)0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Relacorilant (OL Phase)Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.2 / 15229 / 152147 / 152
Relacorilant (RW Phase)Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.0 / 305 / 3022 / 30
Placebo (RW Phase)Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug0 / 321 / 3227 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPivonello R, Arnaldi G, Auchus RJ, Badiu C, Busch RS, Cannavo S, Dischinger U, Dobri GA, Donegan DM, Elenkova A, Fazeli PK, Feelders RA, Garcia-Centeno R, Gilis-Januszewska A, Hamidi O, Hannoush ZC, Kargi AY, Miller HJ, Ranetti AE, Recasens M, Reincke M, Rovner S, Salvatori R, Silverstein J, Stigliano A, Terzolo M, Wang C, Yuen KCJ, Kesner-Hays A, Hand AL, Tudor IC, Araque KA, Moraitis AG; GRACE Study Investigators. Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study. Lancet Diabetes Endocrinol. 2026 Apr;14(4):291-304. doi: 10.1016/S2213-8587(25)00362-6. Epub 2026 Feb 20. PMID 41730814
  • DerivedPivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021. PMID 35058882

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Has a confirmed diagnosis of endogenous Cushing syndrome * Meets at least 1 of the following criteria: * Has Type 2 diabetes mellitus * Has impaired glucose tolerance * Has hypertension. Exclusion Criteria: * Has non-endogenous source of hypercortisolism * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism * Has poorly controlled hypertension * Has poorly controlled diabetes mellitus * Has severe renal insufficiency.

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