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- Title
An Open-label Phase I/IIa Clinical Trial of 11β-HSD1 Inhibitor for Cushing's Syndrome and Autonomous Cortisol Secretion.
- Authors
Satoko Oda; Kenji Ashida; Makiko Uchiyama; Shohei Sakamoto; Nao Hasuzawa; Ayako Nagayama; Lixiang Wang; Hiromi Nagata; Ryuichi Sakamoto; Junji Kishimoto; Koji Todaka; Yoshihiro Ogawa; Yoichi Nakanishi; Masatoshi Nomura
- Abstract
Context: 11ß-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitors demonstrate antimetabolic and antisarcopenic effects in Cushing's syndrome (CS) and autonomous cortisol secretion (ACS) patients. Objective: To confirm the efficacy and safety of S-707106 (11ß-HSD1 inhibitor) administered to CS and ACS patients. Design: A 24-week single-center, open-label, single-arm, dose-escalation, investigatorinitiated clinical trial on a database. Setting: Kyushu University Hospital, Kurume University Hospital, and related facilities. Patients: Sixteen patients with inoperable or recurrent CS and ACS, with mildly impaired glucose tolerance. Intervention: Oral administration of 200 mg S-707106 after dinner, daily, for 24 weeks. In patients with insufficient improvement in oral glucose tolerance test results at 12 weeks, an escalated dose of S-707106 (200 mg twice daily) was administered for the residual 12 weeks. Main Outcome Measures: The rate of participants responding to glucose tolerance impairment, defined as those showing a 25% reduction in the area under the curve (AUC) of plasma glucose during the 75-g oral glucose tolerance test at 24 weeks.
- Subjects
CLINICAL trials; CUSHING'S syndrome; HYDROCORTISONE
- Publication
Journal of Clinical Endocrinology & Metabolism, 2021, Vol 106, Issue 10, pe3865
- ISSN
0021-972X
- Publication type
Article
- DOI
10.1210/clinem/dgab450