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A Trial of Lu AG13909 in Adult Participants With Cushing's Disease

Study acronym: BalanCeD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 21, 2026 (before its estimated September 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 27 to 28v13
  2. Completion moved earlier from Nov 30, 2027 to Oct 31, 2027 Study sites: 26 to 27v12 Show 1 more changeShow less
    • Study sites: 26 to 27
  3. Study sites: 23 to 26v11
  4. Re-verified, no change to tracked fieldsv10
  5. Study sites: 22 to 23v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 20 to 22v8
  2. Site details revised at 5 of 20 sites Eligibility criteria expanded, about 4 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 14 to 20 Completion date: Mar 15, 2028 to Nov 30, 2027v6 Show 1 more changeShow less
    • Completion date: Mar 15, 2028 to Nov 30, 2027
  4. Primary endpoints: 2 to 1 Study sites: 13 to 14 · Completion date: Dec 15, 2027 to Mar 15, 2028 · Secondary endpoints revised (16) · 2 morev5 Show 5 more changesShow less
    • Study sites: 13 to 14
    • Completion date: Dec 15, 2027 to Mar 15, 2028
    • Secondary endpoints revised (16)
    • Study description expanded, about 62 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Feb 7, 2026 to Sep 15, 2026 Study sites: 4 to 13 · Completion date: May 15, 2026 to Dec 15, 2027 · Secondary endpoints reorderedv4 Show 3 more changesShow less
    • Study sites: 4 to 13
    • Completion date: May 15, 2026 to Dec 15, 2027
    • Secondary endpoints reordered
  6. Primary endpoints: 12 to 2 Eligibility criteria expanded, about 6 words · Secondary endpoints: 6 to 16v3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 6 to 16

    See this version in full on ClinicalTrials.gov ↗

  7. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (12) · Study sites: 0 to 4 · Start date changed from estimate of Jun 20, 2024 to Jun 19, 2024 · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (12)
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 20, 2024 to Jun 19, 2024
    • Secondary endpoints revised (6)
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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 Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about 1. the effect of Lu AG13909 on cortisol levels. 2. the safety and tolerability of Lu AG13909. 3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
Trial Details
NCT Number NCT06471829
Lead Sponsor H. Lundbeck A/S
Conditions Cushing's Disease
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov