Phase 3
N=137
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Hypercortisolism
Bottom Line
View on ClinicalTrials.gov: NCT04308590 ↗Enrolled (actual)
137
Serious AEs
13.9%
Results posted
Aug 2025
Primary outcome: Primary: Change in Average 24-hour SBP — -5.56; -2.89 mm Hg — p=0.4160
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Relacorilant (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corcept Therapeutics
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average 24-hour SBP |
-5.56; -2.89 | 0.4160 |
| PRIMARY Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. |
67; 60 | — |
| SECONDARY Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) |
-1.566; 1.008 | — |
| SECONDARY Change in Average Diastolic Blood Pressure (DBP) |
-3.3; -1.4; -3.1; -1.0; -3.0; -0.6 | — |
| SECONDARY Change in Average Heart Rate (HR) |
2.0; -2.0; 1.7; -1.5; 2.2; -2.7 | — |
| SECONDARY Change in Average Daytime and Nighttime SBP |
-4.5; -2.5; -4.6; -3.0 | — |
| SECONDARY Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline |
-0.29; 0.00 | — |
| SECONDARY Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline |
-0.57; -0.19 | — |
| SECONDARY Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL |
1; 0 | — |
| SECONDARY Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL |
6; 7 | — |
| SECONDARY Number of Patients With Any Dose Decrease in Antihypertensive Medication |
7; 5 | — |
| SECONDARY Number of Patients With Any Dose Decrease in Diabetes Medication |
0; 0 | — |
| SECONDARY Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication |
1; 5 | — |
| SECONDARY Number of Patients With Any Dose Increase or Switch in Diabetes Medication |
4; 3 | — |
| SECONDARY Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5% |
3; 4 | — |
| SECONDARY Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg) |
9; 13 | — |
| SECONDARY Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg |
10; 13 | — |
Summary
This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance (DM/IGT) and/or uncontrolled systolic hypertension (HTN).
Eligibility Criteria
Inclusion Criteria
- Shows lack of cortisol suppression on dexamethasone suppression test
- Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
- A radiologically confirmed adrenal lesion
- Has IGT or DM
- Has uncontrolled HTN
Exclusion Criteria
- Has severe, uncontrolled HTN
- Has poorly controlled DM
- Has DM Type 1
- Has significantly abnormal liver test results or severe renal insufficiency
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT04308590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.