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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

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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: 07 Jan 2022

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At a glance

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

Most Recent Events

  • 29 Jan 2021 According to a Novo Nordisk media release, the CHMP recommendation is based on the results from REAL 1, a clinical trial programme investigating the efficacy and safety of Sogroya (somapacitan) in adults with growth hormone deficiency.
  • 29 Jan 2021 According to a Novo Nordisk media release, the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of once-weekly Sogroya (somapacitan), recommending marketing authorisation for the treatment of adults with growth hormone deficiency (AGHD).The CHMP recommends once-weekly Sogroya (somapacitan) to be indicated for the replacement of endogenous growth hormone in adults with AGHD.
  • 28 Aug 2020 According to a Novo Nordisk media release, the U.S. FDA has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10 mg/ 1.5 mL (6.7 mg/mL) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).The FDAs decision is based on a comprehensive clinical program, including this REAL 1 study.

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