Validation of Macimorelin as Test for Adult Growth Hormone Deficiency
Research type
Research Study
Full 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)\n
IRAS ID
190510
Contact name
Nicola Ammer
Contact email
Sponsor organisation
Aeterna Zentaris GmbH
Eudract number
2015-002337-22
Clinicaltrials.gov Identifier
073196, IND number
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Adult Growth Hormone Deficiency (AGHD) is a disease which in adult shows no single signs or symptoms, but it is recognized that AGHD leads to increased morbidity (metabolic syndrome, osteoporosis, muscle wasting, and impaired quality of life) and increased incidence of cardiovascular events, a main cause of the increased mortality observed in this population.\nThe diagnosis of AGHD more often depends on the biochemical tests which are based on growth hormone stimulation tests (GHST). The current standard insulin tolerance test (ITT) has not been developed and approved specifically for AGHD diagnosis, and thus has limitations with regard to performance characteristic (sensitivity of specificity), safety, or feasibility [Molitch et al., 2011; Cook et al., 2009]. For this reason, new tests need to be developed.\nThis study will compare the use of oral macimorelin (study drug) for the diagnosis of AGHD to the use of Insulin Tolerance Test (ITT).\nAt the NHS Trust research sites, male and female 18-56 years old subjects suspected to have AGHD will be assigned to groups of descending likelihood of having AGHD from high, intermediate, and low likelihood of AGHD. The subjects will receive the both GHSTs (macimorelin test and ITT). The sequential order to receive the GHSTs will be determined by stratified randomization with an interval of one to four weeks between the tests.\nThe principle steps of the study will be subject consent, screening visit (interview and blood test), randomization, test visit 1, test visit 2, and End of study visit (final check). The total duration of the subject participation will vary from 2 weeks to 2.5 months depending of screening and visit schedules.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0876
Date of REC Opinion
26 Nov 2015
REC opinion
Further Information Favourable Opinion