Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

Official Title

Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant

Details

This Phase 3 study involves two phases, an open-label (OL) phase and a randomized-withdrawal (RW) phase. Patients will dose-escalate in 100 mg increments to a target dose of 400 mg orally once daily during the open-label phase. Patients will remain on open-label treatment until week 22 at which time they will be evaluated for the randomized-withdrawal phase based on pre-defined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for randomization will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the randomized-withdrawal phase of the study may also be eligible to roll over into an extension study.

Keywords

Cushing Syndrome Cushing disease Hypercortisolemia Cushingoid Type 2 Diabetes Impaired Glucose Intolerance Hypertension Adrenocorticotropic hormone Primary Pigmented Nodular Adrenal Disease Moon Facies Dorsocervical Fat Pad Adrenal Adenoma Adrenal Autonomy Cortisol Cushing Syndrome Relacorilant

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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

Locations

  • Site 36 accepting new patients
    Los Angeles California 90095 United States
  • Site 42 accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corcept Therapeutics
ID
NCT03697109
Phase
Phase 3
Study Type
Interventional
Last Updated