Phase 3
Completed N=152
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
Source: ClinicalTrials.gov NCT03697109 ↗Enrolled (actual)
152
Serious AEs
16.4%
Results posted
Apr 2025
Primary outcomePrimary: Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. — 3; 1; 1; 1 Participants — p=0.0215
◆ Published Evidence
Established
21citations · ~4 / year
Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant.
Summary
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).
Linked Publications (2)
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Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. |
3; 1; 1; 1; 3; 4 | 0.0215 sig |
| PRIMARY Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. |
147; 23; 27 | — |
| SECONDARY Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase |
1.91; 4.81 | — |
| SECONDARY Change in Hemoglobin HbA1c During the RW Phase |
0.06; 0.28 | — |
| SECONDARY Change in 2-hour Plasma Glucose During the RW Phase |
0.52; 2.96 | — |
| SECONDARY Change in SBP and DBP During the RW Phase |
3.95; 10.43; 2.86; 6.53 | — |
| SECONDARY Change in Body Weight During the RW Phase |
-1.21; 0.54 | — |
| SECONDARY Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase |
1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03697109) and the linked publication. 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. Informational only — not medical advice.