Actively Recruiting
A Trial 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
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 genetic testing or elevated 17-OHP
- Morning blood 17-OHP levels greater than four times the upper limit of normal
- Body mass index (BMI) between 18.5 and 40 kg/m2, with a minimum 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 1 month before screening (Part C)
- Generally healthy apart from CAH according to investigator's assessment including medical history, physical exam, vital signs, ECG, and lab tests
You will not qualify if you...
- Pregnant or breastfeeding
- Clinically significant abnormal lab values, ECG, or vital signs at screening indicating risk
- Known hypersensitivity or intolerance to Lu AG13909 or its components
- For Part C only: previous receipt of Lu AG13909 in Parts A or B
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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