Phase
Condition
Congenital Adrenal Hyperplasia
Male Hormonal Deficiencies/abnormalities
Treatment
Lu AG13909
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 ≤35 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.
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.
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Sahlgrenska University Hospital
Gothenburg, 41334
SwedenActive - Recruiting
Karolinska University Hospital/ Huddinge
Huddinge, 141 86
SwedenActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomActive - Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
United KingdomActive - Recruiting
University College London Hospital NHS Foundation Trust
London, NW1 2PG
United KingdomActive - Recruiting
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