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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05307328.
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.
Lead OrganizationSparrow Pharmaceuticals
