A Phase 3 interventional study of Relacorilant and Placebo in Cushing Syndrome, sponsored by Corcept Therapeutics. Completed at 64 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Corcept Therapeutics · Phase 3, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's enrollment of 152 is above the median of 44 across 58 interventional studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 3 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 9 (28%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets at least 1 of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
Drug: Relacorilant
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.
Drug: Relacorilant
Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.
Other: Placebo
Relacorilant is supplied as 100 mg capsules for oral dosing.
Also known as: CORT125134
Placebo matched to study drug
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.
Time frame: 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.
Time frame: OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
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)
Change in Hemoglobin HbA1c During the RW Phase
Time frame: 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).
Time frame: 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.
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Change in Body Weight During the RW Phase
Time frame: 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
Time frame: Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 22 (end of OL Phase)
Mean Change From Baseline in Body Weight During the OL Phase
Time frame: 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.
Time frame: Baseline and Week 22 (end of OL Phase)
Change in Hemoglobin HbA1c During the OL Phase
Time frame: 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.
Time frame: Baseline and Week 22 (end of OL Phase)
| Milestone | Relacorilant (OL Phase) | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|---|
| Started | 152 | 0 | 0 |
| Completed | 95 | 0 | 0 |
| Not completed | 57 | 0 | 0 |
| Withdrew: Adverse event | 24 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 6 | 0 | 0 |
| Withdrew: Withdrawal by subject | 21 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Withdrew: Death | 2 | 0 | 0 |
| Milestone | Relacorilant (OL Phase) | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|---|
| Started | 0 | 30 | 32 |
| Completed | 0 | 27 | 31 |
| Not completed | 0 | 3 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
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.
| Participants | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| SBP | 3 | 1 |
| DBP | 1 | 1 |
| SBP and/or DBP | 3 | 4 |
| Use of rescue medication | 0 | 7 |
| Treatment discontinuation | 2 | 3 |
| Missing ABPM at end of RW Phase | 2 | 3 |
| Participants | Relacorilant (OL Phase) | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|---|
| Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | 147 | 23 | 27 |
| hours x mmol/L | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | 1.91 (-1.138 to 4.966) | 4.81 (2.096 to 7.529) |
| Percentage | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Change in Hemoglobin HbA1c During the RW Phase | 0.06 (-0.270 to 0.383) | 0.28 (-0.022 to 0.578) |
Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).
| mmol/L | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Change in 2-hour Plasma Glucose During the RW Phase | 0.52 (-1.06 to 2.09) | 2.96 (1.55 to 4.37) |
Blood pressure was measured by 24-hour ABPM.
| mm Hg | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| SBP | 3.95 (0.470 to 7.424) | 10.43 (6.538 to 14.329) |
| DBP | 2.86 (-0.199 to 5.928) | 6.53 (3.224 to 9.832) |
| kg | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Change in Body Weight During the RW Phase | -1.21 (-2.685 to 0.269) | 0.54 (-0.851 to 1.939) |
| Participants | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | 1 | 0 |
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.
| score on a scale | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | 0.59 (-4.28 to 5.46) | -0.58 (-5.14 to 3.98) |
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.
| Percent Change | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|
| Absolute Tissue Fat Mass | -0.64 (-1.684 to 0.400) | 1.67 (0.776 to 2.573) |
| Percent Tissue Fat Mass | -0.14 (-1.031 to 0.759) | 1.66 (0.887 to 2.437) |
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.
Results for this outcome have not been posted.
Tissue fat mass was measured by DXA scan.
| Percentage | Relacorilant (OL Phase) |
|---|---|
| Baseline Percent Tissue Fat Mass | 46.4 ± 8.39 |
| Change from Baseline in Percent Tissue Fat Mass at Week 22 | -1.8 ± 2.73 |
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.
| score on a scale | Relacorilant (OL Phase) |
|---|---|
| Baseline Cushing QoL Score | 41.9 ± 19.78 |
| Change from Baseline in Cushing QoL Score | 7.4 ± 14.63 |
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.
| score on a scale | Relacorilant (OL Phase) |
|---|---|
| Baseline BDI-II Score | 16.0 ± 10.24 |
| Change from Baseline in BDI-II Score at Week 22 | -2.8 ± 8.91 |
| kg | Relacorilant (OL Phase) |
|---|---|
| Baseline Body Weight | 93.82 ± 24.734 |
| Change from Baseline in Body Weight at Week 22 | -3.31 ± 5.861 |
Plasma glucose was measured using the 2-hour oGTT.
| mmol/L | Relacorilant (OL Phase) |
|---|---|
| Baseline oGTT | 14.370 ± 4.9402 |
| Change from Baseline in oGTT at Week 22 | -2.117 ± 4.6354 |
| Percentage | Relacorilant (OL Phase) |
|---|---|
| Baseline HbA1c | 7.16 ± 1.626 |
| Change from Baseline in HbA1c at Week 22 | -0.29 ± 1.014 |
Blood pressure was measured by 24-hour ABPM.
| mm Hg | Relacorilant (OL Phase) |
|---|---|
| Baseline SBP | 140.66 ± 10.66 |
| Change from Baseline in SBP at Week 22 | -7.9 ± 9.78 |
| Baseline DBP | 88.9 ± 7.20 |
| Change from Baseline in DBP at Week 22 | -5.4 ± 6.98 |
Collected over OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relacorilant (OL Phase) | 2/152 (1.3%) | 29/152 (19.1%) | 147/152 (96.7%) |
| Relacorilant (RW Phase) | 0/30 (0%) | 5/30 (16.7%) | 22/30 (73.3%) |
| Placebo (RW Phase) | 0/32 (0%) | 1/32 (3.1%) | 27/32 (84.4%) |
| Event | Relacorilant (OL Phase) | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/152 | 1/30 | 0/32 |
| DiverticulitisInfections and infestations | 1/152 | 1/30 | 0/32 |
| Pseudomonal sepsisInfections and infestations | 1/152 | 1/30 | 0/32 |
| HyponatraemiaMetabolism and nutrition disorders | 1/152 | 1/30 | 0/32 |
| GranulomaGeneral disorders | 0/152 | 1/30 | 0/32 |
| Congenital mitral valve incompetenceCongenital, familial and genetic disorders | 0/152 | 0/30 | 1/32 |
| HypotensionVascular disorders | 3/152 | 0/30 | 0/32 |
| HyperkalaemiaMetabolism and nutrition disorders | 2/152 | 0/30 | 0/32 |
| Atrial fibrillationCardiac disorders | 2/152 | 0/30 | 0/32 |
| Acute kidney injuryRenal and urinary disorders | 2/152 | 0/30 | 0/32 |
| Event | Relacorilant (OL Phase) | Relacorilant (RW Phase) | Placebo (RW Phase) |
|---|---|---|---|
| NauseaGastrointestinal disorders | 52/152 | 2/30 | 1/32 |
| Oedema peripheralGeneral disorders | 50/152 | 2/30 | 1/32 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 43/152 | 2/30 | 2/32 |
| Back painMusculoskeletal and connective tissue disorders | 41/152 | 5/30 | 6/32 |
| FatigueGeneral disorders | 34/152 | 0/30 | 0/32 |
| HeadacheNervous system disorders | 31/152 | 3/30 | 4/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 30/152 | 3/30 | 3/32 |
| DiarrhoeaGastrointestinal disorders | 28/152 | 0/30 | 0/32 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 24/152 | 0/30 | 0/32 |
| Abdominal pain upperGastrointestinal disorders | 23/152 | 0/30 | 0/32 |
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.
| Age, Continuous(years) | Relacorilant (OL Phase) |
|---|---|
| Mean | 50.4 ± 13.23 |
| Sex: Female, Male(Participants) | Relacorilant (OL Phase) |
|---|---|
| Female | 127 |
| Male | 25 |
| Ethnicity (NIH/OMB)(Participants) | Relacorilant (OL Phase) |
|---|---|
| Hispanic or Latino | 28 |
| Not Hispanic or Latino | 123 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Relacorilant (OL Phase) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 18 |
| White | 121 |
| More than one race | 6 |
| Unknown or Not Reported | 6 |
| Body weight(kg) | Relacorilant (OL Phase) |
|---|---|
| Mean | 93.77 ± 24.660 |
| Body Mass Index (BMI)(kg/m^2) | Relacorilant (OL Phase) |
|---|---|
| Mean | 34.738 ± 32.675 |
| Waist circumference(cm) | Relacorilant (OL Phase) |
|---|---|
| Mean | 114.85 ± 18.0355 |
| Hypertension (HTN) only(Participants) | Relacorilant (OL Phase) |
|---|---|
| Count of participants | 31 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Relacorilant