ClinicalTrials.gov record NCT05669950
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
A Multi-site, Open-label, Sequential-group, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional trial gives multiple intravenous doses of Lu AG13909 to adults with congenital adrenal hyperplasia (CAH) in sequential parts. It is open-label and tests different dose levels to gather information about safety, how the drug is processed in the body, and how it affects hormone levels. Part C participants may be able to continue in an optional treatment extension.
What it is studying. The study is testing the safety and tolerability of multiple doses of Lu AG13909, how the drug is absorbed, distributed, and eliminated (pharmacokinetics), whether participants develop anti-drug antibodies, and how the drug changes blood levels of hormones such as 17-hydroxyprogesterone (17-OHP) and androstenedione (A4).
What the researchers hope to learn. To learn whether different IV doses of Lu AG13909 are safe and tolerated in adults with CAH; to measure the drug's pharmacokinetics and pharmacodynamic effects on hormone levels; and to track the occurrence of anti-drug antibodies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Lu AG13909
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive multiple intravenous (IV) doses of Lu AG13909 according to the study part they join (Part A, B, or C). They will have repeated safety assessments and blood draws to measure drug levels, hormones (17‑OHP and androstenedione), and anti‑drug antibodies, plus routine safety labs, ECGs, physical exams, and vital‑sign checks. Monitoring and follow-up continue for several months after dosing; participants in Part C may be eligible for an optional treatment extension. The study team will record and monitor any adverse events throughout participation.
How the study is structured. Open-label, sequential-group, multiple-dose drug trial. Participants receive planned intravenous doses in Parts A, B, then C after earlier parts show acceptable safety and tolerability. No masking is used. Part C includes an optional treatment extension for eligible participants.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Denmark, France, Georgia, Ireland, Italy, Poland, Sweden, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on congenital adrenal hyperplasia
Important dates
- Study start
- Dec 19, 2022
- Primary completion
- Sep 30, 2026 (estimated)
- Study completion
- Dec 31, 2027 (estimated)
- Target enrollment
- 42 participants (estimated)
- Last updated on registry
- Mar 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- H. Lundbeck A/S
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Email contact via H. Lundbeck A/S 📞 +45 36301311 ✉ HQ_Medinfo@Lundbeck.com
Participating sites (17)
- University Hospital-University of MichiganRecruiting
Ann Arbor, Michigan, 48109 · United States
- RigshospitaletRecruiting
Copenhagen, 2100 · Denmark
- Chu AngersRecruiting
Angers, 49933 · France
- CHU de LilleRecruiting
Lille, 59000 · France
- GH Pitié-SalpêtrièreRecruiting
Paris, 75013 · France
- CHRU StrasbourgRecruiting
Strasbourg, 67091 · France
- David Metreveli Medical Centre, TbilisiRecruiting
Tbilisi, 0144 · Georgia
- Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), DublinRecruiting
Dublin, D02 YN77 · Ireland
- Azienda Ospedaliero Universitaria di BolognaRecruiting
Bologna, 40138 · Italy
- Azienda Ospedaliero-Universitaria Policlinico Umberto I, RomaRecruiting
Roma, 00161 · Italy
Terms used on this page · explanations by MedicalUpdates.ai
- glucocorticoid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Screening Visit
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- stable dose
- A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
- Cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- electrocardiogram
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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