Effects of Relacorilant on Body Weight and Body Composition in Patients With Endogenous Hypercortisolism in the Phase 3 GRACE and GRADIENT Studies

Summary

Primary endpoint met in GRACE: Relacorilant treatment led to clinically and statistically significant improvements in blood pressure and other signs and symptoms of hypercortisolism
Improvements in glycemic control: Despite well controlled hyperglycemia at baseline, relacorilant treatment improved fasting glucose and HbA1c in GRACE & GRADIENT
Improvements in body composition: Relacorilant led to clinically and statistically significant improvements in body composition and body weight in participants with endogenous hypercortisolism of pituitary, adrenal, and ectopic etiology
- Improvements may occur as early as after 6–10 weeks of treatment
Preserved lean mass: Lean mass was preserved in both studies, in contrast to the reductions in lean mass reported with the most common classes of weight-loss agents
Favorable safety profile: Relacorilant’s selectivity for the glucocorticoid receptor and unique downstream effects result in efficacy without reported cases of relacorilant-induced hypokalemia, adrenal insufficiency, vaginal bleeding associated with endometrial hypertrophy, or QT interval prolongation