Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency With Pituitary Anomalies

In brief

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.

Key facts

Study ID

NCT02558829

Run by

AEterna Zentaris

People needed

157

Starts

2015-12-03

Expected to finish

2016-11-29

Last updated by the study team

2018-04-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• idiopathic childhood onset GHD (without known hypothalamic or pituitary lesion or injury).
• Healthy* control subjects, matching a 'high likelihood GHD' subjects

You may not qualify if…

• 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.
• Subjects with a medical history and clinical signs of a not adequately treated thyroid dysfunction or subjects who had a change in thyroid therapy within 30 days prior to 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.
• Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levodopa, and dopamine agonists) or provoking the release of somatostatin; antimuscarinic agents (atropine).
• Concomitant use of a CYP3A4 inducer (e.g., carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort).
• Medical history of ongoing clinically symptomatic severe psychiatric disorders.
• Parkinson's disease.
• Cushing disease or patients on supraphysiologic glucocorticoid therapy within 30 days prior to the anticipated first test day within the trial.
• Type 1 diabetes or untreated or poorly controlled Type 2 diabetes, as defined by HbA1c > 8%.
• Body mass index (BMI) ≥ 40.0 kg/m2.
• Participation in a trial with any investigational drug within 30 days prior to trial entry.
• Vigorous physical exercise within 24 hours prior to each GHST within this trial.
• Known hypersensitivity to macimorelin or insulin, or any of the constituents of either preparation.
• Clinically significant cardiovascular or cerebrovascular disease.
• Prolonged ECG QT interval, defined as corrected QT interval (QTc) > 500 msec.
• Concomitant treatment with any drugs that might prolong QT/QTc.
• Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (aspartate amino transferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl transpeptidase (GGT)> 2.5 x ULN; ), creatinine, or bilirubin > 1.5x ULN).
• Medical history of seizure disorders.
• Known immunosuppression.
• Current active malignancy other than non-melanoma skin cancer.
• Breastfeeding or positive urine pregnancy test (for women of childbearing potential only).
• Women of childbearing age without contraception, such as hormonal contraception or use of condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD).
• Lack of ability or willingness to give informed consent.
• Anticipated non-availability for trial visits/procedures.

Where it is running

• Harbor UCLA Medical Center — Torrance, California, United States
• Texas Diabetes and Endocrinology — Austin, Texas, United States
• Baylor College of Medicine-Endocrinology — Houston, Texas, United States
• VA Puget Sound Health Care System — Seattle, Washington, United States
• Swedish Medical Center - Cherry Hill — Seattle, Washington, United States
• Krankenanstalt Rudolfstiftung — Vienna, Austria
• Medical University & General Hospital of Vienna, AKH, — Vienna, Austria
• CHU de Lyon HCL-GH Est — Bron, France
• GHU Paris-Sud - Hôpital de Bicêtre — Le Kremlin-Bicêtre, France
• Hôpital Haut-Lévêque — Pessac, France
• Klinikum der LMU München — Munich, Bavaria, Germany
• Max Planck Institut — Munich, Bavaria, Germany
• University Hospital Marburg — Marburg, Hesse, Germany
• RWTH Aachen University Hospital — Aachen, North Rhine-Westphalia, Germany
• Klinik für Endokrinologie, Diabetes und Ernährungsmedizin der Charité — Berlin, Germany
• San Luca Hospital — Milan, Italy
• Centrum Kliniczno-Badawcze — Elblag, Poland
• Centrum Medyczne Angelius Provita — Katowice, Poland
• Phase I - MTZ Clinical Research Sp. z o.o. — Warsaw, Poland
• Wromedica — Wroclaw, Poland
• Clinical Centre of Serbia — Belgrade, Serbia
• Clinical Centre of Vojvodina — Novi Sad, Serbia
• Hospital de Sant Pau — Barcelona, Spain
• Hospital Universitari Vall d' Hebron — Barcelona, Spain
• Hospital de Conxo — Santiago de Compostela, Spain

Full record on ClinicalTrials.gov

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