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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).
The primary outcome is the assessment of efficacy of relacorilant treatment based on sustained blood pressure control during the Randomized-withdrawal (RW) Phase, wherein patients who had achieved the blood pressure response criteria during the Open-label (OL) Phase are randomized to receive either relacorilant or placebo for 12 weeks.
Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relacorilant (OL Phase) | Experimental | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. |
|
| Relacorilant (RW Phase) | Experimental | 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 (RW Phase) | Placebo Comparator | Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant | Drug | Relacorilant is supplied as 100 mg capsules for oral dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | 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. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | 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 Hemoglobin HbA1c During the RW Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. |
Inclusion Criteria:
Has a confirmed diagnosis of endogenous Cushing syndrome
Meets at least 1 of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Moraitis, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 21 | Phoenix | Arizona | 85013 | United States | ||
| Site 36 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41730814 | Derived | Pivonello 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. | |
| 35058882 |
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A total of 404 patients were screened and 152 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Relacorilant (RW Phase) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label (OL) Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2024 | Jun 24, 2025 |
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| Placebo | Other | Placebo matched to study drug |
|
| Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Change in 2-hour Plasma Glucose During the RW Phase | Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT). | Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Change in SBP and DBP During the RW Phase | Blood pressure was measured by 24-hour ABPM. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Change in Body Weight During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) |
| Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Percent Change in Tissue Fat Mass During the RW Phase | Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
| Number of Patients Who Worsened, as Assessed by the Global Clinical Response, During the RW Phase | The Global Clinical Response assessment measures the patient's signs and symptoms of endogenous hypercortisolism in 7 clinical categories: 1) glucose parameters, 2) blood pressure parameters, 3) body composition parameters, 4) clinical appearance, 5) strength parameters, 6) psychiatric health/cognitive function parameters, and 7) quality of life using the Cushing QoL score. The overall response based on the totality of signs and symptoms is rated as +1 for improved, 0 for unchanged, and -1 for worsened. Each patient's final score is the median of ratings given by 3 members of the Data Review Board. | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) |
| Change in Percent Tissue Fat Mass During the OL Phase | Tissue fat mass was measured by DXA scan. | Baseline and Week 22 (end of OL Phase) |
| Change in Cushing QoL Normalized Total Score During the OL Phase | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. | Baseline and Week 22 (end of OL Phase) |
| Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase | The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression. | Baseline and Week 22 (end of OL Phase) |
| Mean Change From Baseline in Body Weight During the OL Phase | Baseline and Week 22 (end of OL Phase) |
| Change in 2-hour Plasma Glucose During the OL Phase | Plasma glucose was measured using the 2-hour oGTT. | Baseline and Week 22 (end of OL Phase) |
| Change in Hemoglobin HbA1c During the OL Phase | Baseline and Week 22 (end of OL Phase) |
| Change in SBP and DBP During the OL Phase | Blood pressure was measured by 24-hour ABPM. | Baseline and Week 22 (end of OL Phase) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Site 68 | Torrance | California | 90502 | United States |
| Site 10 | Miami | Florida | 33136 | United States |
| Site 14 | Atlanta | Georgia | 30318 | United States |
| Site 41 | Chicago | Illinois | 60611 | United States |
| Site 7 | Indianapolis | Indiana | 46202 | United States |
| Site 2 | Metairie | Louisiana | 70006 | United States |
| Site 45 | Baltimore | Maryland | 21205 | United States |
| Site 46 | Boston | Massachusetts | 02115 | United States |
| Site 20 | Ann Arbor | Michigan | 48109 | United States |
| Site 4 | Jackson | Mississippi | 39202 | United States |
| Site 13 | St Louis | Missouri | 63110 | United States |
| Site 53 | Omaha | Nebraska | 68198 | United States |
| Site 72 | Reno | Nevada | 89511 | United States |
| Site 8 | Albany | New York | 12203 | United States |
| Site 6 | Jamaica | New York | 11432 | United States |
| Site 57 | New York | New York | 10021 | United States |
| Site 35 | New York | New York | 10029 | United States |
| Site 39 | New York | New York | 10065 | United States |
| Site 1 | Wilmington | North Carolina | 28401 | United States |
| Site 17 | Columbus | Ohio | 43210 | United States |
| Site 11 | Oklahoma City | Oklahoma | 73104 | United States |
| Site 62 | Philadelphia | Pennsylvania | 19107 | United States |
| Site 19 | Pittsburgh | Pennsylvania | 15212 | United States |
| Site 71 | Pittsburgh | Pennsylvania | 15213 | United States |
| Site 5 | Summerville | South Carolina | 29485 | United States |
| Site 51 | Dallas | Texas | 75390 | United States |
| Site 3 | El Paso | Texas | 79935 | United States |
| Site 65 | Houston | Texas | 77079 | United States |
| Site 56 | Shavano Park | Texas | 78231 | United States |
| Site 31 | Everett | Washington | 98201 | United States |
| Site 47 | Vienna | 1090 | Austria |
| Site 27 | Sofia | 1431 | Bulgaria |
| Site 70 | Halifax | Nova Scotia | B3H-2Y9 | Canada |
| Site 58 | Montreal | H2X 0A9 | Canada |
| Site 54 | München | 80336 | Germany |
| Site 49 | Würzburg | 97080 | Germany |
| Site 30 | Jerusalem | 911120 | Israel |
| Site 29 | Kfar Saba | 4428164 | Israel |
| Site 28 | Petah Tikva | 4941480 | Israel |
| Site 69 | Tel Aviv | Israel |
| Site 43 | Ancona | 60030 | Italy |
| Site 15 | Messina | 98125 | Italy |
| Site 26 | Milan | 20149 | Italy |
| Site 12 | Naples | 80131 | Italy |
| Site 38 | Orbassano | 10043 | Italy |
| Site 67 | Padova | 35128 | Italy |
| Site 40 | Roma | 00161 | Italy |
| Site 16 | Roma | 00189 | Italy |
| Site 34 | Rotterdam | 3015 AA | Netherlands |
| Site 77 | Bialystok | Poland |
| Site 37 | Chrzanów | 32-500 | Poland |
| Site 59 | Krakow | 31- 501 | Poland |
| Site 33 | Lublin | 20-412 | Poland |
| Site 66 | Bucharest | 010825 | Romania |
| Site 63 | Bucharest | 011863 | Romania |
| Site 64 | Bucharest | 011863 | Romania |
| Site 73 | Iași | 700106 | Romania |
| Site 75 | Alicante | 03010 | Spain |
| Site 25 | Girona | 17007 | Spain |
| Site 24 | Madrid | 28007 | Spain |
| Site 22 | Málaga | 29006 | Spain |
| Site 23 | Seville | 41013 | Spain |
| Derived |
| Pivonello 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. |
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. |
| FG002 | 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 drug |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized-withdrawal (RW) Phase |
|
|
The analysis population was patients in the Intent-to-Treat (ITT) Population which included all enrolled patients who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Waist circumference | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Hypertension (HTN) only | HTN is defined as mean systolic blood pressure (SBP) ≥135 or ≤170 mm Hg and/or mean diastolic blood pressure (DBP) ≥85 to ≤110 mm Hg. | Count of Participants | Participants |
| |||||||||||||||||
| Diabetes mellitus (DM) or impaired glucose tolerance (IGT) only | DM is defined as fasting plasma glucose ≥126 mg/dL and/or oral glucose tolerance test plasma glucose ≥200 mg/dL or hemoglobin A1c (HbA1c) ≥6.5%. IGT is defined as plasma glucose ≥140 mg/dL and <200 mg/dL on a 2-hour oral glucose tolerance test. | Count of Participants | Participants |
| |||||||||||||||||
| HTN and DM/IGT | HTN and DM/IGT as previously defined. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | 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. | The analysis population was patients in the Intent-to-Treat (ITT-RW) Population who met the HTN response criteria at conclusion of the OL Phase. The ITT-RW Population included all patients who were randomized in the RW Phase and received at least 1 dose of study drug post randomization. | Posted | Count of Participants | Participants | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | The analysis population was patients in the Safety Population, which included all enrolled patients who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase |
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| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | hours x mmol/L | 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) |
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| Secondary | Change in Hemoglobin HbA1c During the RW Phase | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Secondary | Change in 2-hour Plasma Glucose During the RW Phase | Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT). | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/L | Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Secondary | Change in SBP and DBP During the RW Phase | Blood pressure was measured by 24-hour ABPM. | The analysis population was patients in the ITT-RW Population who had HTN with or without DM/IGT at Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Secondary | Change in Body Weight During the RW Phase | The analysis population was patients in the ITT-RW Population. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Secondary | Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | The analysis population was patients in the ITT-RW Population who had DM/IGT at Baseline and received antidiabetic medication during the RW Phase. | Posted | Count of Participants | Participants | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) |
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| Other Pre-specified | Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. | The analysis population was patients in the ITT-RW Population. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Other Pre-specified | Percent Change in Tissue Fat Mass During the RW Phase | Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass. | The analysis population was patients in the ITT-RW Population. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) |
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| Other Pre-specified | Number of Patients Who Worsened, as Assessed by the Global Clinical Response, During the RW Phase | The Global Clinical Response assessment measures the patient's signs and symptoms of endogenous hypercortisolism in 7 clinical categories: 1) glucose parameters, 2) blood pressure parameters, 3) body composition parameters, 4) clinical appearance, 5) strength parameters, 6) psychiatric health/cognitive function parameters, and 7) quality of life using the Cushing QoL score. The overall response based on the totality of signs and symptoms is rated as +1 for improved, 0 for unchanged, and -1 for worsened. Each patient's final score is the median of ratings given by 3 members of the Data Review Board. | Not Posted | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Percent Tissue Fat Mass During the OL Phase | Tissue fat mass was measured by DXA scan. | The analysis population was patients in the modified ITT-OL (mITT-OL) Population including all enrolled patients who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Percentage | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Change in Cushing QoL Normalized Total Score During the OL Phase | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. | The analysis population was patients in the mITT-OL Population. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase | The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression. | The analysis population was patients in the mITT-OL Population. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Mean Change From Baseline in Body Weight During the OL Phase | The analysis population was patients in the mITT-OL Population. | Posted | Mean | Standard Deviation | kg | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Change in 2-hour Plasma Glucose During the OL Phase | Plasma glucose was measured using the 2-hour oGTT. | The analysis population was patients in the mITT-OL Population who had DM/IGT with or without HTN at Baseline. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Change in Hemoglobin HbA1c During the OL Phase | The analysis population was patients in the mITT-OL Population who had DM/IGT at Baseline. | Posted | Mean | Standard Deviation | Percentage | Baseline and Week 22 (end of OL Phase) |
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| Other Pre-specified | Change in SBP and DBP During the OL Phase | Blood pressure was measured by 24-hour ABPM. | The analysis population was patients in the mITT-OL Population who had HTN at Baseline. | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 22 (end of OL Phase) |
|
|
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 152 | 29 | 152 | 147 | 152 |
| EG001 | 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 | 30 | 5 | 30 | 22 | 30 |
| EG002 | 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 drug | 0 | 32 | 1 | 32 | 27 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cavernous sinus thrombosis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Epididyitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Granuloma | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Congenital mitral valve incompetence | Congenital, familial and genetic disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (26.0) | Systematic Assessment |
|
No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Corcept Therapeutics | 650-327-3270 | info@corcept.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2024 | Apr 7, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D047748 | Pituitary ACTH Hypersecretion |
| D000182 | ACTH Syndrome, Ectopic |
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009384 | Paraneoplastic Endocrine Syndromes |
| D010257 | Paraneoplastic Syndromes |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000633444 | relacorilant |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| SBP and/or DBP |
|
| Use of rescue medication |
|
| Treatment discontinuation |
|
| Missing ABPM at end of RW Phase |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline Body Weight |
|
| ||||
| Change from Baseline in Body Weight at Week 22 |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline HbA1c |
|
| ||||
| Change from Baseline in HbA1c at Week 22 |
|
|
|