A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

NCT07259564 | Not Yet Recruiting Phase 2

• 1 other identifier: GenSci073-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Growth Hormone Deficiency (AGHD)

Keywords

adult growth hormone deficiency; GS3-007a dry suspension

Outcome Measures

Primary Outcomes (1)

• ROC curves and the area under the curve (AUC) of the ROC curves

  up to 120minutes

Secondary Outcomes (2)

• Youden index of the ROC curve for GS3-007a dry suspension

  up to 120minutes

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 22 days

Other Outcomes (3)

• Concentrations of GS3-007a and its metabolite GS3-017 in suspected AGHD subjects

  up to 120minutes

• Serum GH concentration in suspected AGHD subjects

  up to 120minutes

• Positive agreement rate, negative agreement rate, and overall agreement rate between GS3-007a dry suspension and ITT in diagnosing AGHD

  up to 120minutes

Study Arms (3)

GHST Sequence 1

EXPERIMENTAL

GS3-007a low dose, GS3-007a high dose, Insulin Tolerance Test

Drug: GS3-007a dry suspension; Drug: Insulin

GHST Sequence 2

EXPERIMENTAL

GS3-007a high dose, Insulin Tolerance Test, GS3-007a low dose

Drug: GS3-007a dry suspension; Drug: Insulin

GHST Sequence 3

EXPERIMENTAL

Insulin Tolerance Test, GS3-007a low dose, GS3-007a high dose

Drug: GS3-007a dry suspension; Drug: Insulin

Interventions

GS3-007a dry suspension DRUG

GS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose

Also known as: GS3-007a

GHST Sequence 1; GHST Sequence 2; GHST Sequence 3

Insulin DRUG

Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose

Also known as: Insulin Tolerance Test (ITT)

GHST Sequence 1; GHST Sequence 2; GHST Sequence 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Congenital structural/gene defects in the hypothalamus or pituitary gland, or
• History of surgery or radiotherapy in the hypothalamic or pituitary region, or
• Adult traumatic brain injury (TBI) or central nervous system (CNS) infection, or
• Confirmed deficiency of at least one pituitary hormone other than growth hormone (GH), or
• Idiopathic childhood-onset GHD.
• 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):
• Sex;
• Age;

You may not qualify if:

• 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:
• Chronic congestive heart failure (New York Heart Association (NYHA) Class III or higher);
• Other significant cardiovascular/cerebrovascular diseases, e.g., uncontrolled severe hypertension, severe arrhythmia, stroke or transient ischemic attack (TIA), or confirmed coronary artery disease;
• Traumatic brain injury (TBI).
• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Insulin

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Hui Pan, MD

CONTACT

010-69156114; panhui20111111@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 2, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-10

Locations

CN (1)