At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 enrolled
Drug / intervention
Macimorelin +1 moredrug
Likely dose
Macimorelin 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Macimorelin and Insulin for Growth Hormone Deficiency With Pituitary Anomalies. Completed, enrolled 157 participants across 27 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany, Italy, Poland, Serbia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartDec 2015
Primary CompletionNov 2016
TodayJul 2026
First PostedSep 24, 2015
Enrollment StartDec 3, 2015
Primary CompletionNov 29, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.8 years ago
Interventions
Macimorelindrug
macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose
Insulindrug
Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose