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A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
About
Brief 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 and/or uncontrolled hypertension
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Has a confirmed diagnosis of endogenous Cushing syndrome
- Meets at least one of the following criteria:
- Has Type 2 diabetes mellitus
- Has impaired glucose tolerance
- Has hypertension
Exclusion Criteria:
- Has non-endogenous source of hypercortisolemia
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has poorly controlled diabetes mellitus
- Has severe renal insufficiency
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Study Stats
Protocol No.
19-000440
Category
Endocrine and Metabolic Disorders
Principal Investigator
Contact
Location
- UCLA Westwood