Actively Recruiting
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
Led by H. Lundbeck A/S · Updated on 2026-03-09
42
Participants Needed
17
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different doses of Lu AG13909 in adults with congenital adrenal hyperplasia (CAH), a rare genetic disorder that affects hormone production. The study aims to understand the safety, tolerability, how the body processes Lu AG13909, and the body's response to this investigational drug. The research is conducted across multiple phases to assess these aspects carefully. Participants will receive multiple intravenous doses of Lu AG13909 according to specified dosing schedules divided into three parts: Part A, Part B, and Part C. Each part starts after confirming the safety and tolerability of the dose from the previous part. After Part C, participants may have the option to continue treatment in an extension phase. The dosing and treatment schedules are carefully planned and monitored throughout the study. During the trial, participants will undergo regular assessments including blood tests to measure hormone levels like 17-hydroxyprogesterone and androstenedione, as well as monitoring for treatment-emergent adverse events and the presence of anti-drug antibodies. Pharmacokinetic parameters such as serum concentration and elimination half-life of Lu AG13909 will be tracked up to several months. The total participation duration can extend up to about a year or more depending on the study part and extension involvement.
CONDITIONS
Brief Title
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of 21-hydroxylase deficiency CAH based on a pathogenic CYP21A2 variant and/or elevated 17-OHP
- Morning blood levels of 17-OHP more than 4 times the upper limit of normal before glucocorticoid dose
- Body mass index (BMI) of at least 18.5 kg/m2 and no more than 40 kg/m2, with a minimum body weight of 50 kg
- Stable glucocorticoid replacement therapy for at least 1 month before screening
- For salt-wasting CAH, stable mineralocorticoid replacement for at least 3 months before screening (Parts A and B) or at least 1 month for Part C
- Generally healthy apart from CAH based on medical history, physical exam, vital signs, ECG, and lab tests
- For Part C Cohort C1: androgen (A4) blood levels above the upper limit of normal for age and sex
- For Part C Cohort C2: androgen (A4) blood levels at or below the upper limit of normal and treated with high doses of glucocorticoids
You will not qualify if you...
- Pregnant or breastfeeding
- Clinically significant abnormal lab values, ECG, vital signs, or safety findings that pose risk to participant
- Known hypersensitivity or intolerance to Lu AG13909 or its excipients
- For Part C only: previous receipt of at least one dose of Lu AG13909 in Parts A or B
- Other unspecified inclusion and exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 352 days depending on trial part and extension participation
Participants receive multiple intravenous doses of Lu AG13909 according to a prespecified dosing schedule in sequential parts, with safety and tolerability assessed before proceeding to the next part. Participants in Part C may continue in an optional Treatment Extension.
Multiple visits throughout dosing periods up to Day 352
Trial Site Locations
Total: 17 locations
1
University Hospital-University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Chu Angers
Angers, France, 49933
Actively Recruiting
4
CHU de Lille
Lille, France, 59000
Actively Recruiting
5
GH Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
6
CHRU Strasbourg
Strasbourg, France, 67091
Actively Recruiting
7
David Metreveli Medical Centre, Tbilisi
Tbilisi, Georgia, 0144
Actively Recruiting
8
Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin
Dublin, Ireland, D02 YN77
Actively Recruiting
9
Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
10
Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma
Roma, Italy, 00161
Actively Recruiting
11
Centrum Nowoczesnych Terapii, Dobry Lekarz
Dobry Lekarz, Poland, 60-324
Actively Recruiting
12
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
13
Karolinska University Hospital
Stockholm, Sweden, 17174
Actively Recruiting
14
NIHR/Wellcome Trust Clinical Research Facility
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
15
Cambridge Clinical Research Centre
Cambridge, United Kingdom, CB2 0SL
Actively Recruiting
16
NIHR Clinical Research Facility
London, United Kingdom, SE1 9RT
Actively Recruiting
17
University College London Hospital - NIHR
London, United Kingdom, W1T 7HA
Actively Recruiting
Research Team
E
Email contact via H. Lundbeck A/S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here