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A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

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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
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
80 Years

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
Endocrinology
Contact
Gevorg Stepanyan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03697109
For detailed technical eligibility, visit ClinicalTrials.gov.