A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercortisolism
In brief
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).
Key facts
- Study ID
- NCT04308590
- Run by
- Corcept Therapeutics
- People needed
- 137
- Starts
- 2020-07-27
- Expected to finish
- 2024-09-19
- Last updated by the study team
- 2025-09-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 27 — Birmingham, Alabama, United States
- Site 17 — Stanford, California, United States
- Site 53 — Torrance, California, United States
- Site 07 — Atlanta, Georgia, United States
- Site 16 — Indianapolis, Indiana, United States
- Site 09 — Metairie, Louisiana, United States
- Site 36 — Baltimore, Maryland, United States
- Site 11 — Fall River, Massachusetts, United States
- Site 33 — Rochester, Minnesota, United States
- Site 06 — Jackson, Mississippi, United States
- Site 54 — Reno, Nevada, United States
- Site 10 — Jamaica, New York, United States
- Site 44 — New York, New York, United States
- Site 01 — Wilmington, North Carolina, United States
- Site 30 — Cleveland, Ohio, United States
- Site 21 — Columbus, Ohio, United States
- Site 02 — Summerville, South Carolina, United States
- Site 20 — Dallas, Texas, United States
- Site 03 — El Paso, Texas, United States
- Site 05 — Fort Worth, Texas, United States
- Site 08 — Houston, Texas, United States
- Site 15 — Spokane, Washington, United States
- Site 25 — Vienna, State of Vienna, Austria
- Site 22 — Sofia, Bulgaria
- Site 50 — Munich, Bavaria, Germany
Full record on ClinicalTrials.gov
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