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Medical Treatment of Hypercortisolism with Relacorilant: Final Results of the Phase 3 GRACE Study

ABSTRACT

The phase 3 GRACE study (NCT03697109) assessed the efficacy and safety of relacorilant, a selective glucocorticoid receptor modulator, in patients with hypercortisolism and hypertension and/or hyperglycemia (diabetes/impaired glucose tolerance). 152 patients were enrolled ( n = 31 with hypertension; n = 50 with hyperglycemia; n = 71 with both). During the 22-week open-label (OL) phase, rapid and sustained improvements in hypertension and hyperglycemia were observed, along with improvements in several other cortisol-related comorbidities. Patients who achieved prespecified hypertension and/or hyperglycemia response criteria were eligible to enter the 12-week, double-blind, placebo-controlled randomized-withdrawal (RW) phase. The study met its primary endpoint (defined as loss of response in hypertension control between relacorilant and placebo), assessed at the end of the RW phase, with an odds ratio of 0.17 (95% confidence interval 0.04-0.77; P =.02) in favor of relacorilant. See table for hypertension and hyperglycemic results in the OL and RW phases of the study. Relacorilant was well-tolerated in both phases of GRACE with mostly mild-to-moderate adverse events and with little difference between relacorilant and placebo. The most common adverse events in the RW phase were back pain, headache, arthralgia, insomnia, and pain in extremity, similar to the OL phase. No cases of drug-induced irregular vaginal bleeding associated with endometrial hyperplasia, and no QT prolongation (independently confirmed) or adrenal insufficiency were reported.