Growth Hormone Deficiency With Pituitary Anomalies Clinical Trial
Official title:
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)
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.
Trial subjects will be assigned to groups of descending likelihood of having AGHD:
Group A, B, C: High, intermediate, and low likelihood of GHD, respectively; Group D: Healthy
control subjects matching Group A subjects .
The sequential order of the GHSTs for suspected AGHD subjects (Group A-C) will be determined
by stratified randomization; healthy control subjects (Group D) will be tested in the same
sequence as the matched Group A subjects.
Serum concentrations of GH will be measured at pre-defined time points before and after GHST
with macimorelin or insulin. A peak GH value below the GHST-specific cut-off value will be
considered 'test positive'. The ITT will be considered as comparator (non-reference standard)
to assess positive and negative agreement of both GHSTs, based on the predefined cut-off
values.
The following cut-off values for simulated GH levels were used for both GHST tests to be
compared: macimorelin-GHST: GH: 2.8 ng/mL, ITT: GH: 5.1 ng/mL.
Amendment no. 1 (repeatability extension): had been issued for selected sites in Europe to
obtain exploratory data on the repeatability of the MAC in a subset of subjects (planned
N=30, 10 per Group) that had completed the core study.
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