Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

Phase 3 Completed 157 enrolled AEterna Zentaris

RandomizedCrossoverOpen-labelDiagnostic

Summary

The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.

Timeline

Start: 2015-12-03
Primary completion: 2016-11-29
Completion: 2016-11-29

Outcome

Mixed primary results

registry 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'. NCT02558829 ↗

registry positive agreement 74.32 (95% CI 62.84 to 83.78) NCT02558829 ↗

registry negative agreement 93.94 (95% CI 85.20 to 98.32) NCT02558829 ↗

Publications

Garcia JM, Biller BMK, Korbonits M, Popovic V, Luger A, Strasburger CJ, Chanson P, Medic-Stojanoska M, Schopohl J, Zakrzewska A, Pekic S, Bolanowski M, Swerdloff R, Wang C, Blevins T, Marcelli M, Ammer N, Sachse R, Yuen KCJ. Macimorelin as a Diagnostic Test for Adult GH Deficiency. J Clin Endocrinol Metab. 2018 Aug 1;103(8):3083-3093. doi: 10.1210/jc.2018-00665.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin	Protein / enzyme biologic	0.1 iu/kg	Intravenous
Subject	Insulin	Protein / enzyme biologic	0.15 iu/kg	Intravenous
Subject	Macimorelin	Small molecule	0.5 mg/kg	Oral