Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia
About this trial
This is an interventional treatment trial for Congenital Adrenal Hyperplasia
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant 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 of mineralocorticoid replacement for ≥3 months prior to the Screening Visit. Apart from CAH, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ECGs, and the results of the safety laboratory tests. 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 at the 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 AG13909 or its excipients. Other inclusion and exclusion criteria may apply.
Sites / Locations
- University College London Hospital NHS Foundation TrustRecruiting
- Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Experimental
Lu AG13909
Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule.