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ea0041ep937 | Pituitary - Clinical | ECE2016

Trial design of a phase III, multicentre, randomised, double-blind, placebo-controlled, 48-week study to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease

Feelders Richard A , Heaney Anthony , McBride Karen , Hilliard Annie , Tian Chuan , Sauter Nicholas , Auchus Richard J

Background: Osilodrostat is an oral inhibitor of 11β-hydroxylase (CYP11B1), the enzyme that catalyses the final step in cortisol biosynthesis. In a 22-week, phase II study, osilodrostat treatment normalised mean urinary free cortisol (mUFC) in 78.9% (15/19) of patients with uncontrolled Cushings disease and was well tolerated. The present phase 3 study is designed to confirm the safety and efficacy of osilodrostat in patients with uncontrolled Cushings disease...

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ea0035oc8.4 | Pituitary clinical | ECE2014

Normalization of urinary cortisol with the potent 11β-hydroxylase inhibitor LCI699 in patients with Cushing's disease: 22-week, multicentre, open-label study

Biller Beverly , Young Jacques , Hamrahian Amir , Fleseriu Maria , Molitch Mark , Pivonello Rosario , Shimatsu Akira , Shimizu Chikara , Tanaka Tomoaki , White Tracy , Hilliard Annie , Tian Chuan , Sauter Nicholas , Bertagna Xavier

Background: A proof-of-concept study (LINC 1) demonstrated that after 10 weeks, LCI699 normalized UFC in 11/12 patients with Cushings disease. This interim analysis of the first eight patients enrolled into a longer-term study (LINC 2) further evaluates LCI699 in Cushings disease; the full analysis on all 19 enrolled patients is expected in time for the congress.Methods: There were two study groups. Previous LINC 1 participants (follow-up coh...

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Endocrine Abstracts

Trial design of a phase III, multicentre, randomised, double-blind, placebo-controlled, 48-week study to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease

Normalization of urinary cortisol with the potent 11β-hydroxylase inhibitor LCI699 in patients with Cushing's disease: 22-week, multicentre, open-label study

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