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A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

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Trial Profile

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Somapacitan (Primary) ; Somatropin
  • Indications Noonan syndrome; Short stature; Somatotropin deficiency; Turner's syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms Real 8
  • Sponsors Novo Nordisk

Most Recent Events

  • 12 May 2025 Results published in the Media Release
  • 12 May 2025 According to Novo Nordisk media release, in April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US.
  • 12 May 2025 Primary endpoint has been met. (Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS))

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