Adult Growth Hormone Deficiency (AGHD)Phase 2NCT07259564
A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
A Phase 2 study testing GS3-007a dry suspension and Insulin in people with Adult Growth Hormone Deficiency (AGHD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Growth Hormone Deficiency (AGHD)
- What is being tested?
- GS3-007a dry suspension and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to 12 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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;
- BMI;
- (If feasible) Estrogen use and administration route (oral, transdermal) in females:
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult Growth Hormone Deficiency (AGHD)
- Being tested
- GS3-007a dry suspension, Insulin
- Keywords
- adult growth hormone deficiency, GS3-007a dry suspension
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS3-007a dry suspensionDrug
Also called GS3-007a
GS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose
InsulinDrug
Also called Insulin Tolerance Test (ITT)
Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| GHST Sequence 1 | Experimental | GS3-007a low dose, GS3-007a high dose, Insulin Tolerance Test Receives: Drug: GS3-007a dry suspension; Drug: Insulin |
| GHST Sequence 2 | Experimental | GS3-007a high dose, Insulin Tolerance Test, GS3-007a low dose Receives: Drug: GS3-007a dry suspension; Drug: Insulin |
| GHST Sequence 3 | Experimental | Insulin Tolerance Test, GS3-007a low dose, GS3-007a high dose Receives: Drug: GS3-007a dry suspension; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curves and the area under the curve (AUC) of the ROC curves
Measured: up to 120minutes
Secondary outcomes (2)
Youden index of the ROC curve for GS3-007a dry suspension
Measured: up to 120minutes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start19 Dec 2025
- Primary completion15 Apr 2026
- Study completion12 May 2026
Why it stopped: Adjustment of sponsor's product development strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone Deficiency (AGHD)Studies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259564
- Sponsor's protocol ID
- GenSci073-202
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07259564
- Acronym / sponsor ID
- GenSci073-202
- Conditions
- Adult Growth Hormone Deficiency (AGHD)
- Keywords
- adult growth hormone deficiency, GS3-007a dry suspension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of sponsor's product development strategy.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GHST Sequence 1 | Experimental | Drug: GS3-007a dry suspension, Drug: InsulinGS3-007a low dose, GS3-007a high dose, Insulin Tolerance Test |
| GHST Sequence 2 | Experimental | Drug: GS3-007a dry suspension, Drug: InsulinGS3-007a high dose, Insulin Tolerance Test, GS3-007a low dose |
| GHST Sequence 3 | Experimental | Drug: GS3-007a dry suspension, Drug: InsulinInsulin Tolerance Test, GS3-007a low dose, GS3-007a high dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Age ≥ 18 years and ≤ 65 years, male or female.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS3-007a dry suspensionAlso: GS3-007aGS3-007a dry suspension, low dose body weight, drinking solution, single dose GS3-007a dry suspension, high dose body weight, drinking solution, single dose | Drug | GHST Sequence 1, GHST Sequence 2, GHST Sequence 3 |
| InsulinAlso: Insulin Tolerance Test (ITT)Insulin, 0.10 -0.15 U/kg, intravenous injection, single dose | Drug | GHST Sequence 1, GHST Sequence 2, GHST Sequence 3 |
Primary outcome
ROC curves and the area under the curve (AUC) of the ROC curves
Time frame: up to 120minutes
2 secondary outcomes
Youden index of the ROC curve for GS3-007a dry suspension
Time frame: up to 120minutes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 22 days
Results and safety
The study was stopped early (reason given: Adjustment of sponsor's product development strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS3-007a dry suspension and Insulin in people with Adult Growth Hormone Deficiency (AGHD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adjustment of sponsor's product development strategy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROC curves and the area under the curve (AUC) of the ROC curves (time frame: up to 120minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.