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A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 9, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 8 to 17v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study sites: 7 to 8v6
  4. Study sites: 5 to 7 Primary completion date: Sep 1, 2026 to Sep 30, 2026 · Completion date: Feb 1, 2028 to Dec 31, 2027v5 Show 2 more changesShow less
    • Primary completion date: Sep 1, 2026 to Sep 30, 2026
    • Completion date: Feb 1, 2028 to Dec 31, 2027
  5. Phase: Phase 1 to Phase 1/2 Enrollment target: 12 to 42 · Primary completion date: Dec 28, 2024 to Sep 1, 2026 · Primary endpoints: 11 to 12 · 4 morev4 Show 7 more changesShow less
    • Enrollment target: 12 to 42
    • Primary completion date: Dec 28, 2024 to Sep 1, 2026
    • Primary endpoints: 11 to 12
    • Completion date: Dec 28, 2024 to Feb 1, 2028
    • Eligibility criteria expanded, about 127 words
    • Secondary endpoints expanded, about 39 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 2 to 5v3
  2. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
H. Lundbeck A/S
20 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT05669950
Lead Sponsor H. Lundbeck A/S
Conditions Congenital Adrenal Hyperplasia
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov