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

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

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.

It had three arms (groups): GHST Sequence 1 (experimental), GHST Sequence 2 (experimental) and GHST Sequence 3 (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 15 inclusion and 27 exclusion criteria; among the exclusions: known or suspected hypersensitivity to growth hormone secretagogues (ghs) or their excipients or known allergy to insulin or its excipients; chronic congestive heart failure (new york heart association (nyha) class iii or higher);; traumatic brain injury (tbi).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-12-19 with completion listed for 2026-04-15.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

Primary outcome: ROC curves and the area under the curve (AUC) of the ROC curves (time frame: up to 120minutes).

It also tracked 2 secondary outcomes, for example Youden index of the ROC curve for GS3-007a dry suspension and Number of Participants With Treatment Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 120 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.