The objectives of this study are: to estimate SPI-62's effect on clinical features of hypercortisolism related to a benign adrenal tumor including diabetes/impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia; to evaluate the safety of SPI-62 in patients with hypercortisolism related to a benign adrenal tumor, including changes on hypothalamic pituitary adrenal (HPA) and hypothalamic pituitary gonadal (HPG) axes biomarkers and associated AEs; and to assess the pharmacological effect of SPI-62 on hepatocellular cortisol/cortisone equilibrium in patients with hypercortisolism related to a benign adrenal tumor. The study is a multicenter, randomized, double-blind, placebo-controlled study. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a 31-day screening period, a 12-week treatment period, and a 30-day follow-up period. Each subject will be randomized to receive 1 of 4 dose levels of SPI-62 or matching placebo for 12 weeks.
This will be a randomized, double-blind study to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.