Conditions: Growth Hormone Deficiency With Pituitary Anomalies
Keywords: Adult Growth Hormone Deficiency
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 157
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: 1st Macimorelin-GHST, 2nd Insulin Tolerance Test arm 2: 1st Insulin Tolerance Test, 2nd Macimorelin-GHST

Interventions: intervention 1: Macimorelin intervention 2: Insulin
Intervention descriptions: intervention 1: macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose intervention 2: Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose

Protocol document: