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
Price :
$35
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At a glance
- Drugs Macimorelin (Primary) ; Insulin
- Indications Somatotropin deficiency
- Focus Diagnostic use; Registrational
- Sponsors AEterna Zentaris Inc
- 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