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A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin FlexPro) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

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Trial Profile

A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin FlexPro) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Dec 2023

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At a glance

  • Drugs Somapacitan (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms REAL 3
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 28 Oct 2023 This trial has been completed in Germany (Date of the global end of the trial: 02-Oct-2023), according to the European Clinical Trials Database record.
    • 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.
    • 30 Mar 2023 Results(n=50) assessing efficacy and safety of somapacitan, and associated disease/treatment burden, after 4 years of treatment and 1 year after switching to somapacitan from daily GH published in the Journal of Clinical Endocrinology and Metabolism
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