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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cushing's Syndrome I, Cushing Disease Due to Increased ACTH Secretion, Cortisol Excess, Cortisol; Hypersecretion, Cortisol Overproduction, Ectopic ACTH Secretion

In brief

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.

Key facts

Study ID

NCT05307328

Run by

Sparrow Pharmaceuticals

People needed

26

Starts

2022-09-01

Expected to finish

2025-08-01

Last updated by the study team

2025-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization.
• 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.
• 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.
• Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.

Where it is running

• St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary Center — Phoenix, Arizona, United States
• Southwest General Healthcare Center — Fort Myers, Florida, United States
• Mayo Clinic Cancer Center (MCCC) - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine - Center for Advanced Medicine (CAM) — St Louis, Missouri, United States
• Comprehensive and Interventional Pain Management Llp — Henderson, Nevada, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Oregon Health & Science University (OHSU) - Northwest Pituitary Center — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of Plovdiv — Plovdiv, Bulgaria
• Clinical Center of Endocrinology and Gerontology, University Hospital of Endocrinology, Medical University Sofia (USHATE) — Sofia, Bulgaria
• Medical University of Sofia — Sofia, Bulgaria
• Carol Davila University of Medicine and Pharmacy — Bucharest, Romania

Full record on ClinicalTrials.gov

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