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A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Trial Profile

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2019

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At a glance

  • Drugs Somapacitan (Primary) ; Somatrogon
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms REAL 1
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 18 Mar 2019 Results presented at the 101st Annual Meeting of the Endocrine Society
    • 23 Jan 2019 This trial has been completed in Latvia (End date: 2018-05-07), according to European Clinical Trials Database.
    • 19 Jul 2018 Status changed from active, no longer recruiting to completed.
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