Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Last updated: July 3, 2024
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

1

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

Lu AG13909

Clinical Study ID

NCT05669950
19873A
  • Ages 18-55
  • All Genders

Study Summary

This study 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 study 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:

  • 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 ≤35 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.

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.

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Lu AG13909
Phase: 1
Study Start date:
December 19, 2022
Estimated Completion Date:
December 28, 2024

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg, 41334
    Sweden

    Active - Recruiting

  • Karolinska University Hospital/ Huddinge

    Huddinge, 141 86
    Sweden

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • University College London Hospital NHS Foundation Trust

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

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