A Phase 2 interventional study of SPI-62 and Placebo in Cushing's Syndrome I, Cushing Disease Due to Increased ACTH Secretion and Cortisol Excess, sponsored by Sparrow Pharmaceuticals. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Sparrow Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's enrollment of 26 is below the median of 44 across 58 interventional studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →Sparrow Pharmaceuticals is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active drug by mouth each morning for up to 12 weeks
Drug: SPI-62 · Drug: Placebo
Placebo by mouth each morning for up to 12 weeks
Drug: SPI-62 · Drug: Placebo
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
Inactive tablets identical to SPI-62 tablets
Change from baseline in urinary HSD-1 ratio
The urinary HSD-1 ratio (tetrahydrocortisol + allotetrahydrocortisol ) / tetrahydrocortisone will be used as a biomarker of HSD-1 activity in liver. The primary analysis will include only subjects with Cushing's disease.
Time frame: Baseline to 6 weeks
Treatment emergent adverse events
Adverse events including clinically significant abnormal values on clinical laboratory evaluations, continuous glucose monitoring (CGM), 12-lead ECGs, vital signs measurements (including orthostatic vital sign measurements), physical examinations, and HPA and HPG axis biomarkers
Time frame: Baseline through 24 weeks of treatment
Ran from Sep 2022 to primary completion in Aug 2025, 35 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ASP3662
Sparrow Pharmaceuticals