Clinical trial · Interventional
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypercortisolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Relacorilant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Relacorilant
- description
- Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
- interventionNames
- Drug: Relacorilant
- Other: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will receive placebo matched to study drug once daily.
- interventionNames
- Other: Placebo
Primary outcomes (2)
- measure
- Change in Average 24-hour SBP
- timeFrame
- Baseline and Week 22
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available