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A Study of Lu AG13909 for Congenital Adrenal Hyperplasia (CAH)

This study is testing a drug called Lu AG13909 in adults with Congenital Adrenal Hyperplasia (CAH), a rare genetic condition affecting hormone production. The main goals are to understand if Lu AG13909 is safe, how well people tolerate it, and how the body processes and responds to the drug. To join, you must be between 18 and 70 years old, have a confirmed diagnosis of 21-hydroxylase deficiency CAH with specific elevated hormone levels, and meet certain BMI requirements. This study aims to enroll 42 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive the study drug Lu AG13909. It plans to enroll 42 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and drug levels will be measured up to Day 161 after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05669950

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Recruiting
PHASE1Ages 18–70InterventionalTreatment
H. Lundbeck A/S
~42 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Lu AG13909

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured over Up to Day 161
+11 more outcomes measured

Conditions

Congenital Adrenal Hyperplasia

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NCT05669950

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

    Roma, Italyno site contact published

    Recruiting

  • Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin

    Dublin, Irelandno site contact published

    Recruiting

  • Cambridge Clinical Research Centre

    Cambridge, United Kingdomno site contact published

    Recruiting

  • Centrum Nowoczesnych Terapii, Dobry Lekarz

    Dobry Lekarz, Polandno site contact published

    Recruiting

  • CHRU Strasbourg

    Strasbourg, Franceno site contact published

    Recruiting

  • Chu Angers

    Angers, Franceno site contact published

    Recruiting

  • CHU de Lille

    Lille, Franceno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.
The participant has received at least one dose of Lu AG13909 in Part A or Part B.

What this trial measures

  • Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Up to Day 161
  • Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs)Day 1 up to Day 161
  • Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax0 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: Ctrough: Minimum Observed Serum Concentration of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: t½: Apparent Elimination Half-life of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: CL: Apparent Total Serum Clearance of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG139090 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Parts A and B: Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)Baseline up to Day 85
  • Parts A and B: AUC0-tau: Area under the curve over a dosing interval0 (predose) up to 24 hours postdose on Day 1 to Day 161
  • Part C: Morning Concentration of A4 in Blood <Upper Limit of Normal (ULN)Day 169