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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 8 of 22 entries
    • Site details revised at 2 of 17 sites
  2. 4 versions Re-verified since May 26, 2026, no change to tracked fieldsv30-v33
  3. Study sites: 18 to 17v29
  4. Trial sites reduced: 22 → 18 locationsv28
  5. Study sites: 31 to 22v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study sites: 36 to 31v26
  2. Re-verified, no change to tracked fieldsv25
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Nov 2026 to Oct 2026
    • Site details revised at 36 of 36 sites
    v24
  4. Study sites: 37 to 36v23
  5. Study sites: 42 to 37v22
  6. Site details revised at 1 of 42 sitesv21
  7. Study sites: 43 to 42v20
  8. Site details revised at 1 of 43 sitesv19
  9. Study sites: 44 to 43v18
  10. Enrollment target: 53 to 56v17 Show 5 more changesShow less
    • Study sites: 45 to 44
    • Primary completion date: Dec 2026 to Nov 2026
    • Study completion date: Mar 2028 to Feb 2028
    • Eligibility criteria expanded, about 138 words
    • Study title shortened, about 2 words
  11. Study sites: 44 to 45v16
  12. Study sites: 43 to 44v15
  13. Study sites: 39 to 43v14
  14. Study sites: 33 to 39
    • Primary completion date: Jul 2026 to Dec 2026
    • Study completion date: Dec 2027 to Mar 2028
    v13
  15. Study sites: 25 to 33v12
  16. Study sites: 20 to 25v11
  17. Study sites: 9 to 20
    • Study completion date: Sep 2027 to Dec 2027
    • Start date changed from estimate of Jul 2024 to Jul 31, 2024
    v10
  18. Re-verified, no change to tracked fieldsv9
  19. Study sites revised (9)v8
  20. Start date: Apr 2024 to Jul 2024
    • Study sites: 7 to 9
    v7
  21. Study sites: 4 to 7v6
  22. Start date: Feb 2024 to Apr 2024
    • Study sites: 2 to 4
    • Primary completion date: May 2026 to Jul 2026
    v5
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v4
  24. Start date: Dec 2023 to Feb 2024v3
  25. Re-verified, no change to tracked fieldsv2
  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.
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with central precocious puberty (CPP).
Trial Details
NCT Number NCT06129539
Lead Sponsor Debiopharm International SA
Conditions
(from sponsor)		 Central Precocious Puberty
Related terms Puberty, Precocious
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov