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A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin SimpleXx in Children With Growth Hormone Deficiency

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Trial Profile

A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin SimpleXx in Children With Growth Hormone Deficiency

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Aug 2023

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At a glance

  • Drugs Somapacitan (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Adverse reactions
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 18 Jun 2023 Results evaluating the model-based analysis of dose insulin-like growth factor-I (IGF-I) responses of once-weekly somapacitan compared to daily GH in pediatric patients with GHD, presented at the 105th Annual Meeting of the Endocrine Society.
    • 31 Jul 2021 According to EudraCT record the trial status is completed in Spain.
    • 17 Apr 2021 Results Pooled modelling analysis of data from ClinicalTrials.gov identifiers NCT01973244, NCT00936403 and NCT01706783 published in the Clinical Pharmacokinetics

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