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Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 24 words
    • Study sites revised (51)
  2. Study sites: 50 to 51v36
  3. Study sites: 49 to 50v35
  4. Study sites: 47 to 49v34
  5. Study sites: 46 to 47v33
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 45 to 46v32
  2. Study sites: 44 to 45v31
  3. Study sites: 43 to 44v30
  4. Study sites: 42 to 43v29
  5. Study sites: 40 to 42v28
  6. Study sites: 39 to 40v27
  7. Study sites: 38 to 39v26
  8. Study sites: 37 to 38v25
  9. Study sites: 36 to 37v24
  10. Study sites: 35 to 36v23
  11. Study sites: 33 to 35v22
  12. Study sites: 32 to 33v21
  1. Trial sites expanded: 29 → 32 locationsv20
  2. Start date changed from estimate of Apr 2026 to May 20, 2026v19
  3. Study sites: 28 to 29v18
  4. Study sites: 26 to 28v17
  5. Trial sites expanded: 23 → 26 locationsv16
  6. Study sites: 21 to 23v15
  7. Study sites: 20 to 21v14
  8. Study sites: 17 to 20v13
  9. Study sites: 16 to 17v12
  10. Start date: Jan 2026 to Apr 2026
    • Study sites: 13 to 16
    v11
  11. Study sites: 12 to 13v10
  12. Study sites: 11 to 12v9
  13. Study sites: 10 to 11v8
  14. Study sites: 8 to 10v7
  15. Study sites: 7 to 8v6
  16. Study sites: 6 to 7
    • Start date: Dec 2025 to Jan 2026
    v5
  17. Start date: Oct 2025 to Dec 2025
    • Study sites: 5 to 6
    v4
  18. Study sites: 1 to 5v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2025 to Oct 2025
    • Study sites: 0 to 1
    v2
  20. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.
Trial Details
NCT Number NCT06948214
Lead Sponsor Lumos Pharma
Conditions
(from sponsor)		 Growth Hormone Deficiency (GHD)
Related terms Dwarfism, Pituitary
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov