SUN-451 A Randomized-Withdrawal, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Selective Glucocorticoid Receptor Antagonist, Relacorilant, in Patients with Cushing Syndrome (GRACE Study)

ABSTRACT: Abstract Relacorilant is a highly selective glucocorticoid receptor antagonist (GRA) that modulates the effects of excess cortisol while showing no affinity for progesterone, mineralocorticoid, androgen, or estrogen receptors. In a phase 2 study, treatment with relacorilant showed improvement in glycemic and hypertension endpoints as well as other manifestations of cortisol excess in patients with endogenous Cushing syndrome (CS). Relacorilant was well tolerated, with no instances of drug-related hypokalemia or antiprogesterone effects. A multicenter phase 3 clinical trial of relacorilant is underway (GRACE Study: NCT03697109) that uses a randomized withdrawal (RW) design to evaluate efficacy and safety. Based on the mechanism of action of GRAs, clinical efficacy endpoints are being used.

SUBMITTER: Auchus R 

PROVIDER: S-EPMC6553349 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature