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Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders

StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 47 → 51 locations
    • Trial sites expanded: 43 → 47 locations
  2. Lead sponsor: Ascendis Pharma A/S to Ascendis Pharma A/S Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Study sites: 43 to 47
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 5 entries
  3. Trial sites expanded: 40 → 43 locationsv20
  4. Trial sites expanded: 36 → 40 locationsv19
  5. Study sites: 34 to 36v18
  6. Trial sites expanded: 30 → 34 locationsv17
  7. Trial sites expanded: 26 → 30 locationsv16
  8. Study sites: 25 to 26v15
  9. Trial sites expanded: 19 → 23 locationsv14
  10. Trial sites expanded: 15 → 19 locationsv13
  11. Study sites: 15 to 19v12
  12. Study sites: 14 to 15v11
  13. Study sites: 13 to 14v10
  14. Study sites: 11 to 13v9
  15. Study sites: 9 to 11v8
  16. Study sites: 7 to 9v7
  17. Study sites: 5 to 7v6
  18. Study sites: 4 to 5v5
  19. Study sites: 3 to 4v4
  20. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Nov 2025 to Dec 12, 2025
    v3
  21. Eligibility criteria shortened, about 20 wordsv2
  22. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.
Trial Details
NCT Number NCT07221851
Lead Sponsor Ascendis Pharma A/S
Conditions
(from sponsor)		 Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
Related terms Chromosome Disorders, Dwarfism, Endocrine System Diseases, Failure to Thrive, Noonan Syndrome, Sex Chromosome Disorders, Sex Chromosome Disorders of Sex Development, Turner Syndrome
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov