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Last Updated: November 15, 2019

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CLINICAL TRIALS PROFILE FOR OSILODROSTAT

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Clinical Trials for Osilodrostat

Trial ID Title Status Sponsor Phase Summary
NCT02372084 A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function Completed Novartis Pharmaceuticals Phase 1 To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
NCT02399202 A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function Completed Novartis Pharmaceuticals Phase 1 To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.
NCT02468193 Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome Recruiting Novartis Pharmaceuticals Phase 2 The study aim is to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.
NCT02697734 Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease Recruiting Novartis Pharmaceuticals Phase 3 Purpose of study is to aim to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy
NCT03606408 Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 Recruiting Novartis Pharmaceuticals Phase 2 The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.
NCT03708900 Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease Not yet recruiting Novartis Pharmaceuticals Phase 2 Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Osilodrostat

Condition Name

Condition Name for
Intervention Trials
Cushing's Syndrome 2
Cushing's Disease 2
Ectopic Corticotropin Syndrome 1
AIMAH 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Pituitary ACTH Hypersecretion 2
ACTH-Secreting Pituitary Adenoma 2
Syndrome 2
Cushing Syndrome 2
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Clinical Trial Locations for Osilodrostat

Trials by Country

Trials by Country for
Location Trials
Spain 4
Japan 4
United States 3
Greece 1
Austria 1
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Trials by US State

Trials by US State for
Location Trials
New York 1
Minnesota 1
Florida 1
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Clinical Trial Progress for Osilodrostat

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Osilodrostat

Sponsor Name

Sponsor Name for
Sponsor Trials
Novartis Pharmaceuticals 6
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
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