NCT03697109

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 (DM/IGT) and/or uncontrolled hypertension (HTN).

Detailed description

The primary outcome is the assessment of efficacy of relacorilant treatment based on sustained blood pressure control during the Randomized-withdrawal (RW) Phase, wherein patients who had achieved the blood pressure response criteria during the Open-label (OL) Phase are randomized to receive either relacorilant or placebo for 12 weeks. Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined 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 the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.

Conditions

• Cushing Syndrome

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant is supplied as 100 mg capsules for oral dosing.
OTHER	Placebo	Placebo matched to study drug

Timeline

• Start date: 2018-11-15
• Primary completion: 2024-04-08
• Completion: 2024-04-15
• First posted: 2018-10-05
• Last updated: 2025-07-16
• Results posted: 2025-04-24

Locations

64 sites across 11 countries: United States, Austria, Bulgaria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study