A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Start Date
6/19/2024
Completion Date
10/31/2027
Summary
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about 1. the effect of Lu AG13909 on cortisol levels. 2. the safety and tolerability of Lu AG13909. 3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
Detailed Description
This trial is divided into 3 parts: * Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period * Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period * Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Lu AG13909
Conditions
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States
Centre Hospitalier Universitaire d'Angers
Angers, Cedex 09 49933
France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, Europe 13005
France
Hopital Louis Pradel
Bron, 69677
France
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
France
Centre Hospitalier Universitaire De Lille
Lille, 59000
France
Hopital Haut-Leveque
Pessac, 33604
France
Ltd Tbilisi Central Hospital
Tbilisi, Europe 0159
Georgia
National Institute of Endocrinology
Tbilisi, Europe 0159
Georgia
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi, Europe 0186
Georgia
Ltd Aversi Clinic
Tbilisi, 160
Georgia
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
University Hospital of Pecs
Pécs, 7624
Hungary
Azienda Ospedale Università di Padova
Padova, Europe 35128
Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Europe 56124
Italy
Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino'
Messina, Sicily 98124
Italy
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, 00189
Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Italy
University Hospital in Krakow
Krakow, 30-688
Poland
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863
Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Clju-Napoca, 400347
Romania
Spitalul Clinic Judetean Mures
Mures, 540139
Romania
Hospital de la Santa Creu i de Sant Pau
Barcelona, 08041
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Northern Care Alliance, North Manchester General Hospital
Manchester, Europe M8 5RB
United Kingdom
University of Birmingham Institute of Metabolism and Systems Research
Birmingham, B15 2TT
United Kingdom