NCT05307328

SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.

Detailed description

This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period (Days -35 to -8), a baseline period (Days -7 to -1), and a treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24) and, the option of long-term extension. Subjects have the option to continue with the study on active study drug and return to the site every 3 months for blood tests and study drug dispensing. The visits may be conducted remotely if testing can be arranged.

Conditions

• Cushing's Syndrome I
• Cushing Disease Due to Increased ACTH Secretion
• Cortisol Excess
• Cortisol; Hypersecretion
• Cortisol Overproduction
• Ectopic ACTH Secretion

Interventions

Type	Name	Description
DRUG	SPI-62	11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
DRUG	Placebo	Inactive tablets identical to SPI-62 tablets

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2022-04-01
• Last updated: 2025-10-08

Locations

12 sites across 3 countries: United States, Bulgaria, Romania

Regulatory

• FDA-regulated drug study