Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05436639
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2022-06-23
Brief Title:
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Sponsor:
Sparrow Pharmaceuticals
Organization:
Sparrow Pharmaceuticals
Study Overview
Official Title:
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACSPIRE
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
Detailed Description:
This is a multicenter open-label single-arm study Phase 2 study to estimate SPI-62s effect on clinical features of hypercortisolism related to a benign adrenal tumor including diabetesimpaired 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 screeningbaseline months 1 3 6 9 and 12 and then quarter-annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None