Trials / Completed
CompletedNCT05436639
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Sparrow Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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-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.
Conditions
- Autonomous Cortisol Secretion (ACS)
- ACTH-Independent Cushing Syndrome
- ACTH-Independent Adrenal Cushing Syndrome, Somatic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPI-62 dose | SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg). |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-12-01
- Completion
- 2025-02-18
- First posted
- 2022-06-29
- Last updated
- 2026-02-13
Locations
5 sites across 3 countries: United States, Romania, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05436639. Inclusion in this directory is not an endorsement.