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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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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

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