Adults 18 to 80, any sex, with Cushing Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.Primary· Week 22 (end of OL Phase) and Week 36 (Week 12 of 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 p
SBP
Group
Value
95% CI
Relacorilant (RW Phase)
3
Placebo (RW Phase)
1
DBP
Group
Value
95% CI
Relacorilant (RW Phase)
1
Placebo (RW Phase)
1
SBP and/or DBP
Group
Value
95% CI
Relacorilant (RW Phase)
3
Placebo (RW Phase)
4
Use of rescue medication
Group
Value
95% CI
Relacorilant (RW Phase)
0
Placebo (RW Phase)
7
Treatment discontinuation
Group
Value
95% CI
Relacorilant (RW Phase)
2
Placebo (RW Phase)
3
Missing ABPM at end of RW Phase
Group
Value
95% CI
Relacorilant (RW Phase)
2
Placebo (RW Phase)
3
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.Primary· OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
Group
Value
95% CI
Relacorilant (OL Phase)
147
Relacorilant (RW Phase)
23
Placebo (RW Phase)
27
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW PhaseSecondary· 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)
Group
Value
95% CI
Relacorilant (RW Phase)
1.91
-1.138 – 4.966
Placebo (RW Phase)
4.81
2.096 – 7.529
Change in Hemoglobin HbA1c During the RW PhaseSecondary· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Group
Value
95% CI
Relacorilant (RW Phase)
0.06
-0.270 – 0.383
Placebo (RW Phase)
0.28
-0.022 – 0.578
Change in 2-hour Plasma Glucose During the RW PhaseSecondary· Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).
Group
Value
95% CI
Relacorilant (RW Phase)
0.52
-1.06 – 2.09
Placebo (RW Phase)
2.96
1.55 – 4.37
Change in SBP and DBP During the RW PhaseSecondary· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Blood pressure was measured by 24-hour ABPM.
SBP
Group
Value
95% CI
Relacorilant (RW Phase)
3.95
0.470 – 7.424
Placebo (RW Phase)
10.43
6.538 – 14.329
DBP
Group
Value
95% CI
Relacorilant (RW Phase)
2.86
-0.199 – 5.928
Placebo (RW Phase)
6.53
3.224 – 9.832
Change in Body Weight During the RW PhaseSecondary· Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
Group
Value
95% CI
Relacorilant (RW Phase)
-1.21
-2.685 – 0.269
Placebo (RW Phase)
0.54
-0.851 – 1.939
Number of Patients With Any Increase or Modification in Diabetes Medication During the RW PhaseSecondary· Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)
Group
Value
95% CI
Relacorilant (RW Phase)
1
Placebo (RW Phase)
0
Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW PhaseSecondary· Week 22 (end of OL Phase) and Week 36 (Week 12 of 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.
Group
Value
95% CI
Relacorilant (RW Phase)
0.59
-4.28 – 5.46
Placebo (RW Phase)
-0.58
-5.14 – 3.98
Percent Change in Tissue Fat Mass During the RW PhaseSecondary· Week 22 (end of OL Phase) and Week 36 (Week 12 of 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.
Absolute Tissue Fat Mass
Group
Value
95% CI
Relacorilant (RW Phase)
-0.64
-1.684 – 0.400
Placebo (RW Phase)
1.67
0.776 – 2.573
Percent Tissue Fat Mass
Group
Value
95% CI
Relacorilant (RW Phase)
-0.14
-1.031 – 0.759
Placebo (RW Phase)
1.66
0.887 – 2.437
Change in Percent Tissue Fat Mass During the OL PhaseSecondary· Baseline and Week 22 (end of OL Phase)
Tissue fat mass was measured by DXA scan.
Baseline Percent Tissue Fat Mass
Group
Value
95% CI
Relacorilant (OL Phase)
46.4
± 8.39
Change from Baseline in Percent Tissue Fat Mass at Week 22
Group
Value
95% CI
Relacorilant (OL Phase)
-1.8
± 2.73
Change in Cushing QoL Normalized Total Score During the OL PhaseSecondary· Baseline and Week 22 (end of 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 Cushing QoL Score
Group
Value
95% CI
Relacorilant (OL Phase)
41.9
± 19.78
Change from Baseline in Cushing QoL Score
Group
Value
95% CI
Relacorilant (OL Phase)
7.4
± 14.63
Adverse events — posted to ClinicalTrials.gov
Time frame: OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05726292 — A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-r
· Phase 2
· recruiting
NCT05347979 — Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy
· Phase 1
· completed
NCT04795479 — T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
· Phase 1
· completed
NCT04373265 — Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Mu
· Phase 1
· completed
NCT04308590 — A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
· Phase 3
· completed
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Other Corcept Therapeutics trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corcept Therapeutics
Last refreshed: 16 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03697109.