A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Last updated: March 6, 2026
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

1/2

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

Lu AG13909

Clinical Study ID

NCT05669950
19873A
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Parts A and B:

  • Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2variant 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 ofmineralocorticoid replacement for ≥3 months prior to the Screening Visit.

  • Apart from CAH, the participant is generally healthy in the opinion of theinvestigator 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 CYP21A2variant and/or elevated 17-OHP).

  • For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations ofandrogens (A4) > ULN for age and sex.

  • For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations ofandrogens (A4) ≤ ULN for age and sex and the participant is treated with high dosesof 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 ofmineralocorticoid replacement for ≥1 month prior to the Screening Visit.

Exclusion

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 atthe 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 AG13909or 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 Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Lu AG13909
Phase: 1/2
Study Start date:
December 19, 2022
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Chu Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHU de Lille

    Lille, 59000
    France

    Active - Recruiting

  • GH Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • GH Pitié-Salpêtrière

    Paris 2988507, 75013
    France

    Site Not Available

  • CHRU Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • David Metreveli Medical Centre, Tbilisi

    Tbilisi, 0144
    Georgia

    Active - Recruiting

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

    Dublin, D02 YN77
    Ireland

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

    Roma, 00161
    Italy

    Active - Recruiting

  • Centrum Nowoczesnych Terapii, Dobry Lekarz

    Dobry Lekarz, 60-324
    Poland

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg 2711537, 413 45
    Sweden

    Site Not Available

  • Karolinska University Hospital/ Huddinge

    Huddinge, 141 86
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm, 17174
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm 2673730, 17174
    Sweden

    Site Not Available

  • NIHR/Wellcome Trust Clinical Research Facility

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • NIHR/Wellcome Trust Clinical Research Facility

    Birmingham 2655603, B15 2TH
    United Kingdom

    Site Not Available

  • Cambridge Clinical Research Centre

    Cambridge, CB2 0SL
    United Kingdom

    Active - Recruiting

  • Cambridge Clinical Research Centre

    Cambridge 2653941, CB2 0SL
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • NIHR Clinical Research Facility

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • University College London Hospital - NIHR

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • University College London Hospital NHS Foundation Trust

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • NIHR Clinical Research Facility

    London 2643743, SE1 9RT
    United Kingdom

    Active - Recruiting

  • University College London Hospital - NIHR

    London 2643743, W1T 7HA
    United Kingdom

    Site Not Available

  • University Hospital-University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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