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A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor 2 versions Re-verified since Dec 19, 2025, no change to tracked fieldsv26-v27
  2. Minor Primary completion date changed from estimate of Dec 2024 to Oct 18, 2024v25
  3. Minor Study completion date: Jun 2026 to Dec 2027
    • Secondary endpoints: details revised at 4 of 4 entries
    v24
  4. Minor Re-verified, no change to tracked fieldsv23
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 19
    • Primary completion date: Oct 2025 to Dec 2024
    • Study completion date: Oct 2025 to Jun 2026
    v22
Show 20 earlier versionsHide 20 earlier versions
  1. Minor Site details revised at 1 of 24 sitesv21
  2. Minor Site details revised at 1 of 24 sitesv20
  3. Minor Site details revised at 2 of 24 sitesv19
  4. Minor Site details revised at 1 of 24 sitesv18
  5. Minor Site details revised at 1 of 24 sitesv17
  6. Minor Site details revised at 1 of 24 sitesv16
  7. Minor Study sites: 23 to 24v15
  8. Minor Study sites: 22 to 23v14
  9. Minor Site details revised at 1 of 22 sitesv13
  10. Minor Study sites: 21 to 22v12
  11. Minor Site details revised at 2 of 21 sitesv11
  12. Minor Study sites: 19 to 21v10
  13. Minor Site details revised at 3 of 19 sitesv9
  14. Minor Site details revised at 3 of 19 sitesv8
  15. Minor Study sites: 18 to 19v7
  16. Minor Site details revised at 1 of 18 sitesv6
  17. Minor Site details revised at 1 of 18 sitesv5
  18. Minor Start date changed from estimate of Jan 2023 to Feb 15, 2023
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 1 of 18 sites
    v4
  19. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 18 of 18 sites
    v3
  20. Minor Interventions: Lonapegsomatropin (Biological), Somatropin (Device) to Lonapegsomatropin (Biological), Somatropin (Drug)
    • Study title shortened, about 19 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individuals per arm) will be randomized to receive one of three doses of lonapegsomatropin or a daily injection of somatropin. This is a trial that will be conducted in the United States.
Trial Details
NCT Number NCT05690386
Lead Sponsor Ascendis Pharma Endocrinology Division A/S
Conditions
(from sponsor)
Turner Syndrome
Related terms Turner Syndrome
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov