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

Phase II Clinical Study of Single Oral Administration of GS3-007a for Oral Suspension in the Diagnosis of AGHD: A Multicenter, Randomized, Open-Label, Three-Way Crossover Trial

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.

Study Overview

• Status: Terminated
• Conditions: Adult Growth Hormone Deficiency (AGHD)
• Intervention / Treatment: Drug: GS3-007a dry suspension; Drug: Insulin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  • 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):

  1. Sex;
  2. Age;
  3. BMI;
  4. (If feasible) Estrogen use and administration route (oral, transdermal) in females:

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:

  1. Chronic congestive heart failure (New York Heart Association (NYHA) Class III or higher);
  2. Other significant cardiovascular/cerebrovascular diseases, e.g., uncontrolled severe hypertension, severe arrhythmia, stroke or transient ischemic attack (TIA), or confirmed coronary artery disease;
  3. 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GHST Sequence 1; GS3-007a low dose, GS3-007a high dose, Insulin Tolerance Test	Drug: GS3-007a dry suspension; GS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose; Other Names: GS3-007a; Drug: Insulin; Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose; Other Names: Insulin Tolerance Test (ITT)
Experimental: GHST Sequence 2; GS3-007a high dose, Insulin Tolerance Test, GS3-007a low dose	Drug: GS3-007a dry suspension; GS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose; Other Names: GS3-007a; Drug: Insulin; Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose; Other Names: Insulin Tolerance Test (ITT)
Experimental: GHST Sequence 3; Insulin Tolerance Test, GS3-007a low dose, GS3-007a high dose	Drug: GS3-007a dry suspension; GS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose; Other Names: GS3-007a; Drug: Insulin; Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose; Other Names: Insulin Tolerance Test (ITT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ROC curves and the area under the curve (AUC) of the ROC curves	up to 120minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): May 12, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: adult growth hormone deficiency; GS3-007a dry suspension
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Bone Diseases, Endocrine; Bone Diseases, Developmental; Dwarfism; Hypopituitarism; Dwarfism, Pituitary; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Proinsulin; Insulin
• Other Study ID Numbers: GenSci073-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No