At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Lu AG13909 (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Lu AG13909 — drug: Solution for infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is testing a medicine called Lu AG13909 in people with congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency. It has three parts (A, B and C) and is run by the sponsor H. Lundbeck A/S. Its main aim is not stated — ask the trial team.
Who can take part
- A confirmed diagnosis of CAH due to 21-hydroxylase deficiency (shown by a faulty CYP21A2 gene and/or high levels of a hormone called 17-OHP).
- Morning blood levels of 17-OHP more than 4 times the upper limit of normal before taking your usual steroid (glucocorticoid) medicine (Parts A and B).
- A body mass index between 18.5 and 40, and a weight of at least 50 kilograms (Parts A and B).
- Taking a stable dose of steroid (glucocorticoid) replacement medicine for at least 1 month before the screening visit.
- If you have the salt-wasting form of CAH, being on a stable dose of mineralocorticoid replacement medicine for at least 3 months (Parts A and B) or at least 1 month (Part C) before screening.
- Being generally healthy apart from CAH, based on checks such as your medical history, an examination, vital signs, heart tracing (ECG) and safety blood tests.
- For Part C, Cohort C1 only: morning blood levels of androgens (A4) above the normal limit for your age and sex.
- For Part C, Cohort C2 only: morning blood levels of androgens (A4) within the normal limit and being treated with high doses of steroids (glucocorticoids).
Who may not be able to
- Being pregnant or breastfeeding.
- Having a clinically significant abnormal blood result, heart tracing (ECG), vital sign or other safety finding at screening that could pose a risk, in the researcher's opinion.
- Having a known allergy or bad reaction to Lu AG13909 or its other ingredients.
- For Part C only: having already received at least one dose of Lu AG13909 in Part A or Part B.
- Other inclusion and exclusion criteria may apply.
What taking part involves
- • Taking the study medicine Lu AG13909. Details of how it is given are not stated — ask the trial team.
Time commitment: Number of visits and how long the trial lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 42
- Started
- 2022-12-19
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for congenital adrenal hyperplasia
- • Phase1/Phase2 - 42 participants
- • This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with congenital adrenal hyperplasia
Where?
- • Birmingham - NIHR/Wellcome Trust Clinical Research Facility
- • Cambridge - Cambridge Clinical Research Centre
- • London - NIHR Clinical Research Facility
- • London - University College London Hospital - NIHR
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ been on a stable dose of mineralocorticoid replacement for ≥3 months
- ✓ been on a stable dose of mineralocorticoid replacement for ≥1 month
What the study is looking for
- ✓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...
- ✓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.
Who cannot take part
- ✗The participant is pregnant or breastfeeding.
- ✗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.
See the full criteria
Where Is This Study? (4 UK sites)
NIHR/Wellcome Trust Clinical Research Facility
Birmingham B15 2TH, United Kingdom
Cambridge Clinical Research Centre
Cambridge CB2 0SL, United Kingdom
NIHR Clinical Research Facility
London SE1 9RT, United Kingdom
University College London Hospital - NIHR
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825How to Get in Touch
Email contact via H. Lundbeck A/S
Sponsor contactCONTACT