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Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)

Trial Profile

Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2022

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At a glance

  • Drugs Macimorelin (Primary) ; Insulin
  • Indications Somatotropin deficiency
  • Focus Diagnostic use; Registrational
  • Sponsors AEterna Zentaris Inc

Most Recent Events

  • 25 May 2022 According to an AEterna Zentaris media release, European approval of Ghryvelin was granted in 2019.
  • 18 Mar 2019 Results of a post hoc analysis assessing the percent agreement and sensitivity and specificity of Macimorelin vs ITT over a range of GH cutpoints, presented at the 101st Annual Meeting of the Endocrine Society
  • 18 Mar 2019 Results presented at the 101st Annual Meeting of the Endocrine Society

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