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The GS3-007a Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, three-way crossover trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.
Full description
Trial subjects will be assigned to groups of descending likelihood of having AGHD:
Group A: High likelihood of AGHD Group B: Intermediate likelihood of AGHD Group C: Low likelihood of AGHD Group D: Healthy control subjects matched to Group A. The sequential of the GHSTs for Group A-C will be determined by randomization. Group D will undergo testing in the same sequence as their matched Group A counterparts Serum growth hormone (GH) concentrations will be measured at predefined time points before and after GHST with GS3-007a or insulin. The peak GH value and diagnostic cut-off for GS3-007a dry suspension will be evaluated using receiver operating characteristic (ROC) curves. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) outcomes were assessed for GS3-007a. The Insulin Tolerance Test (ITT) served as the comparator to determine positive and negative agreement with GS3-007a GHSTs.
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Inclusion criteria
Suspected AGHD Subjects (Groups A, B, and C):
Age ≥ 18 years and ≤ 65 years, male or female.
Suspected AGHD, meeting at least one of the following criteria:
IGF-1 SDS < 0.
Willing and able to comply with the study procedures and voluntarily sign the informed consent form.
Matched Healthy Control Subjects (Group D):
Age ≥ 18 years and ≤ 65 years, male or female.
Matching criteria with Group A (subjects with highly suspected AGHD):
Exclusion criteria
Known or suspected hypersensitivity to growth hormone secretagogues (GHS) or their excipients or known allergy to insulin or its excipients.
Clinically significant conditions newly diagnosed within 6 months before screening, making the subject unsuitable for ITT:
Short-acting GH therapy within 30 days before screening.
Long-acting GH therapy within 90 days before screening.
GH stimulation test performed within 7 days before the first dose.
Abnormal thyroid function during screening, or any adjustment to thyroid hormone replacement therapy dosage prior to the first study dose.
Abnormal gonadal function during screening, or any adjustment to testosterone/estrogen replacement therapy dosage prior to the first study dose.
Abnormal adrenal function during screening, or any adjustment to glucocorticoid replacement therapy dosage prior to the first study dose.
Type 1 diabetes diagnosed before screening, or uncontrolled Type 2 diabetes
Body mass index (BMI) ≥40.0 kg/m².
Major surgery (e.g., coronary bypass, hepatectomy/nephrectomy, gynecologic surgery) within 6 months before screening.
Acute neurological, digestive, respiratory, circulatory, endocrine, or hematologic diseases within 3 months before screening, judged by the investigator to potentially affect drug absorption, distribution, metabolism, excretion (ADME), or safety evaluation.
History or current diagnosis of malignancy (any type) before screening.
Electrocardiogram (ECG) findings during screening indicating QTc interval >450 ms, or history of corrected QT interval (QTc) prolongation, or other clinically significant ECG abnormalities, or use of medications known to prolong QTc interval.
Sellar region MRI scan during screening showing untreated intracranial tumor growth.
History of clinically symptomatic psychiatric disorders persisting at screening.
History of Parkinson's disease or epilepsy persisting at screening.
Females with positive blood human chorionic gonadotropin (hCG) during screening, or lactating females, or females planning pregnancy from screening through follow-up completion.
Liver function abnormalities during screening
Use of medications directly affecting pituitary GH secretion or somatostatin-releasing drugs within a period >5 half-lives before first study dose.
Use of strong cytochrome P450 family 3 subfamily A member 4/5 (CYP3A4/5) inhibitors or inducers.
Participation in any other drug or medical device clinical trial within 1 month prior to screening, or screening occurring within 5 half-lives of the investigational drug (whichever is longer).
Unwillingness to use protocol-specified contraception methods
Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial.
Primary purpose
Allocation
Interventional model
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120 participants in 3 patient groups
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Central trial contact
Hui Pan, MD
Data sourced from clinicaltrials.gov
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