Phase
Condition
Congenital Adrenal Hyperplasia
Male Hormonal Deficiencies/abnormalities
Treatment
Lu AG13909
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Parts A and B:
Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2variant and/or elevated 17-OHP).
Morning (pre-glucocorticoid [GC] replacement dose) blood concentrations of 17-OHP >4-times upper limit of normal (ULN).
Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m^2) (minimum 50 kg) and ≤40 kg/m^2.
Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
For the salt-wasting form of CAH, the participant must have been on a stable dose ofmineralocorticoid replacement for ≥3 months prior to the Screening Visit.
Apart from CAH, the participant is generally healthy in the opinion of theinvestigator and based on medical history, physical examination, vital signs, ECGs,and the results of the safety laboratory tests.
Part C:
Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2variant and/or elevated 17-OHP).
For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations ofandrogens (A4) > ULN for age and sex.
For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations ofandrogens (A4) ≤ ULN for age and sex and the participant is treated with high dosesof GC.
Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
For the salt-wasting form of CAH, the participant must have been on a stable dose ofmineralocorticoid replacement for ≥1 month prior to the Screening Visit.
Exclusion
Exclusion Criteria:
The participant is pregnant or breastfeeding.
The participant has a clinically significant abnormal laboratory value,electrocardiogram (ECG) parameter, or vital signs value, or other safety findings atthe Screening Visit that indicate a potential risk for the participant if enrolled,in the opinion of the investigator.
The participant has a history of known hypersensitivity or intolerance to Lu AG13909or its excipients.
Part C Only:
- The participant has received at least one dose of Lu AG13909 in Part A or Part B.
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkSite Not Available
Chu Angers
Angers, 49933
FranceActive - Recruiting
CHU de Lille
Lille, 59000
FranceActive - Recruiting
GH Pitié-Salpêtrière
Paris, 75013
FranceActive - Recruiting
GH Pitié-Salpêtrière
Paris 2988507, 75013
FranceSite Not Available
CHRU Strasbourg
Strasbourg, 67091
FranceActive - Recruiting
David Metreveli Medical Centre, Tbilisi
Tbilisi, 0144
GeorgiaActive - Recruiting
Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin
Dublin, D02 YN77
IrelandActive - Recruiting
Azienda Ospedaliero Universitaria di Bologna
Bologna, 40138
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma
Roma, 00161
ItalyActive - Recruiting
Centrum Nowoczesnych Terapii, Dobry Lekarz
Dobry Lekarz, 60-324
PolandActive - Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
SwedenActive - Recruiting
Sahlgrenska University Hospital
Gothenburg 2711537, 413 45
SwedenSite Not Available
Karolinska University Hospital/ Huddinge
Huddinge, 141 86
SwedenSite Not Available
Karolinska University Hospital
Stockholm, 17174
SwedenActive - Recruiting
Karolinska University Hospital
Stockholm 2673730, 17174
SwedenSite Not Available
NIHR/Wellcome Trust Clinical Research Facility
Birmingham, B15 2TH
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomSite Not Available
NIHR/Wellcome Trust Clinical Research Facility
Birmingham 2655603, B15 2TH
United KingdomSite Not Available
Cambridge Clinical Research Centre
Cambridge, CB2 0SL
United KingdomActive - Recruiting
Cambridge Clinical Research Centre
Cambridge 2653941, CB2 0SL
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
United KingdomActive - Recruiting
NIHR Clinical Research Facility
London, SE1 9RT
United KingdomActive - Recruiting
University College London Hospital - NIHR
London, W1T 7HA
United KingdomActive - Recruiting
University College London Hospital NHS Foundation Trust
London, NW1 2PG
United KingdomSite Not Available
NIHR Clinical Research Facility
London 2643743, SE1 9RT
United KingdomActive - Recruiting
University College London Hospital - NIHR
London 2643743, W1T 7HA
United KingdomSite Not Available
University Hospital-University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting

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