Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human) and Macimorelin (non-peptide).

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.

It had two arms (groups): GHST Sequence A (experimental) and GHST Sequence B (experimental).

1st Macimorelin-GHST, 2nd Insulin Tolerance Test.

1st Insulin Tolerance Test, 2nd Macimorelin-GHST.

The registry classes the interventions as drug.

More on the Plan

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'.

Who Took Part

157 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Suspected growth hormone deficiency (GHD), based on either of the following:. Structural hypothalamic or pituitary disease, or. Surgery or irradiation in these areas, or. Head trauma as an adult, or. Evidence of other pituitary hormone deficiencies, or.

The full record lists 7 inclusion and 25 exclusion criteria; among the exclusions: GH therapy within 1 month prior to anticipated first GHST within this trial (within 3 months in case of long-acting GH formulation); GHST within 7 days prior to the anticipated first test day within the trial; untreated hypogonadism or not on a stable substitution treatment within 30 days prior to anticipated first test day within the trial.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2015-12-03 with completion listed for 2016-11-29.

It ran at 27 sites in United States (5), Germany (5), Poland (4), France (3), Spain (3) and Austria (2).

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 3 secondary outcomes, for example Overall Agreements (Positive/ Negative) for MAC and ITT.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Macimorelin (non-peptide) in 157 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Macimorelin (non-peptide) compound page, all human trials.