NCT04308590CompletedPhase 3
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 · Last updated 4 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 27 Feb 2020
- Start date
- 27 Jul 2020
- Primary completion date
- 19 Sept 2024
- Lead sponsor
- Corcept Therapeutics
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT04308590
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 137
- From 27 Jul 2020 to the primary completion date, 19 Sept 2024
- 45 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has significantly abnormal liver test results or severe renal insufficiency
Other
- Has severe, uncontrolled HTN
- Has poorly controlled DM
- Has DM Type 1
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.