NCT02558829

Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Growth Hormone Deficiency With Pituitary Anomalies

Interventions

Type	Name	Description
DRUG	Macimorelin	macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose
DRUG	Insulin	Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose

Timeline

• Start date: 2015-12-03
• Primary completion: 2016-11-29
• Completion: 2016-11-29
• First posted: 2015-09-24
• Last updated: 2018-04-10
• Results posted: 2018-02-09

Locations

27 sites across 9 countries: United States, Austria, France, Germany, Italy, Poland, Serbia, Spain, United Kingdom