CompletedPhase 2
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Key facts
- Who runs it
- Sparrow Pharmaceuticals
- Where
- Fort Myers, Henderson, New York, Phoenix, Pittsburgh, Portland, Rochester, and St Louis, United StatesSee the 8 sitesAlso in 2 other countries, 4 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 26 people enrolled
- Started
- 1 Sept 2022
- Ended
- 1 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- SPI-62
- Placebo
- Record updated
- 8 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Male or non-menstruating female
- 18 years or older
- Active and consistent cortisol excess
- Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion
Who cannot take part
- Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization
- Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products
- History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years
- History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions)
- High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures
- Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence
Where in United States
Also in 2 other countries, 4 sites
- Southwest General Healthcare CenterFort Myers, United StatesNo longer taking part
- Comprehensive and Interventional Pain Management LlpHenderson, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary CenterPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- Oregon Health & Science University (OHSU) - Northwest Pituitary CenterPortland, United StatesNo longer taking part
- Mayo Clinic Cancer Center (MCCC) - RochesterRochester, United StatesNo longer taking part
- Washington University School of Medicine - Center for Advanced Medicine (CAM)St Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SPI-62Treatment being tested
Active drug by mouth each morning for up to 12 weeks
Treatment: SPI-62 and Placebo
- PlaceboPlacebo, for comparison
Placebo by mouth each morning for up to 12 weeks
Treatment: SPI-62 and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 October 2025