clinical trial · NCT05436639
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Autonomous Cortisol Secretion (ACS)ACTH-Independent Cushing SyndromeACTH-Independent Adrenal Cushing Syndrome, SomaticSPI-62 dose
brief summary
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.
started
Jul 1, 2023
primary completion
Dec 1, 2024
completion
Feb 18, 2025
last updated
Feb 13, 2026
detailed description
This is a multicenter, open-label, single-arm study, Phase 2 study 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. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period and an open-ended treatment period. Visits occur at screening/baseline, months 1, 3, 6, 9, and 12, and then quarter-annually.
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