A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
Completed · Phase 3 · Has a placebo group
Conditions studied: Cushing Syndrome
In brief
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).
Key facts
- Study ID
- NCT03697109
- Run by
- Corcept Therapeutics
- People needed
- 152
- Starts
- 2018-11-15
- Expected to finish
- 2024-04-15
- Last updated by the study team
- 2025-07-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Site 36 — Los Angeles, California, United States
- Site 68 — Torrance, California, United States
- Site 10 — Miami, Florida, United States
- Site 14 — Atlanta, Georgia, United States
- Site 41 — Chicago, Illinois, United States
- Site 7 — Indianapolis, Indiana, United States
- Site 2 — Metairie, Louisiana, United States
- Site 45 — Baltimore, Maryland, United States
- Site 46 — Boston, Massachusetts, United States
- Site 20 — Ann Arbor, Michigan, United States
- Site 4 — Jackson, Mississippi, United States
- Site 13 — St Louis, Missouri, United States
- Site 53 — Omaha, Nebraska, United States
- Site 72 — Reno, Nevada, United States
- Site 8 — Albany, New York, United States
- Site 6 — Jamaica, New York, United States
- Site 57 — New York, New York, United States
- Site 35 — New York, New York, United States
- Site 39 — New York, New York, United States
- Site 1 — Wilmington, North Carolina, United States
- Site 17 — Columbus, Ohio, United States
- Site 11 — Oklahoma City, Oklahoma, United States
- Site 62 — Philadelphia, Pennsylvania, United States
- Site 19 — Pittsburgh, Pennsylvania, United States
- Site 21 — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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