NCT05669950 A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
| NCT ID | NCT05669950 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | H. Lundbeck A/S |
| Condition | Congenital Adrenal Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2022-12-19 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2022-12-19 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this trial are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.
Eligibility Criteria
Inclusion Criteria: Parts A and B: * 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 ≤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 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. Part C: * Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP). * For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) \> ULN for age and sex. * For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) ≤ ULN for age and sex and the participant is treated with high doses of 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 of mineralocorticoid replacement for ≥1 month prior to the Screening Visit. 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. 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.
Contact & Investigator
Email contact via H. Lundbeck A/S
STUDY DIRECTOR
HQ_Medinfo@Lundbeck.com
Frequently Asked Questions
Who can join the NCT05669950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Congenital Adrenal Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05669950 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05669950 currently recruiting?
Yes, NCT05669950 is actively recruiting participants. Contact the research team at HQ_Medinfo@Lundbeck.com for enrollment information.
Where is the NCT05669950 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Copenhagen, Denmark, Angers, France, Lille, France and 11 additional locations.
Who is sponsoring the NCT05669950 clinical trial?
NCT05669950 is sponsored by H. Lundbeck A/S. The principal investigator is Email contact via H. Lundbeck A/S at HQ_Medinfo@Lundbeck.com. The trial plans to enroll 42 participants.