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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

Study acronym: OXTEND™-03
StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 6 of 73 sites
  2. Study sites: 72 to 73v20
  3. Re-verified, no change to tracked fieldsv19
  4. Study sites: 71 to 72v18
  5. Site details revised at 2 of 71 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Re-verified, no change to tracked fieldsv16
  2. Study sites: 70 to 71v15
  3. Site details revised at 4 of 70 sitesv14
  4. Study sites: 67 to 70v13
  5. Study sites: 58 to 67v12
  6. Study sites: 44 to 58
    • Start date changed from estimate of Nov 2025 to Nov 26, 2025
    v11
  7. Study sites: 32 to 44v10
  8. Start date: Sep 2025 to Nov 2025
    • Study sites: 16 to 32
    v9
  9. Start date: Jul 2025 to Sep 2025v8
  10. Study sites: 5 to 16v7
  11. Start date: Jun 2025 to Jul 2025
    • Site details revised at 1 of 5 sites
    v6
  12. Study sites: 4 to 5v5
  13. Study sites: 2 to 4v4
  14. Study sites: 1 to 2
    • Start date: May 2025 to Jun 2025
    • Eligibility criteria revised
    v3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Trial Details
NCT Number NCT06930625
Lead Sponsor Debiopharm International SA
Conditions
(from sponsor)		 Acromegaly
Related terms Acromegaly, Gigantism, Pituitary Diseases
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov