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A Multi-site, Open-label, Sequential-group, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

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Trial Profile

A Multi-site, Open-label, Sequential-group, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Lu AG13909 (Primary)
  • Indications Congenital adrenal hyperplasia
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Lundbeck A/S

Most Recent Events

  • 24 Jun 2025 According to a Lundbeck Inc media release, the expanded trial will enroll men and women with classic CAH, under stable glucocorticoid dosing and will be divided into two cohorts hyperandrogenemia, and the second will include participants with normal androgen levels, but treated with supraphysiologic glucocorticoid doses. Participants may enter an optional open-label extension, where they receive monthly Lu AG13909 over a period of 12 months.
  • 24 Jun 2025 According to a Lundbeck Inc media release, the trial will open for enrolment in North America and seven countries across Europe, with the first sites opening in late June 2025.
  • 30 May 2025 Phase of trial changed to I/II

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