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

Summary  

• Relacorilant is a selective glucocorticoid receptor (GR) modulator in development for the treatment of endogenous hypercortisolism
• GRACE was a phase 3, randomized-withdrawal (RW) study assessing the efficacy and safety of relacorilant in patients with hypercortisolism and hypertension and/ or hyperglycemia (diabetes/impaired glucose tolerance [IGT])
• Significant improvements in hypertension, hyperglycemia, and other manifestations of cortisol excess were observed throughout the treatment with relacorilant
• Due to relacorilant’s specificity for the GR and its unique mechanism of action, the observed efficacy was seen: Without cases of relacorilant-induced irregular vaginal bleeding with endometrial hypertrophy
  • Without increases in cortisol concentrations and relacorilant-induced hypokalemia
  • Without reported cases of adrenal insufficiency
  • Without independently confirmed QT prolongation

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