At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 152 enrolled
Drug / intervention
Relacorilant +1 moredrug
Likely dose
Relacorilant 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Relacorilant and Placebo for Cushing Syndrome. Completed, enrolled 152 participants across 64 sites in 11 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing Syndrome
CountriesAustria, Bulgaria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionApr 2024
Study CompletionApr 2024
TodayJul 2026
First PostedOct 5, 2018
Enrollment StartNov 15, 2018
Primary CompletionApr 8, 2024
Study CompletionApr 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.7 years ago
Interventions
Relacorilantdrug
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placeboother
Placebo matched to study drug