Could a drink replace daily shots for growth hormone deficiency?
NCT ID NCT07264595
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This study tests an oral medicine called GS3-007a for children with growth hormone deficiency. In the first part, kids receive different doses or a placebo for 14 days to check safety. In the second part, they take the chosen dose or a standard injection for 52 weeks to see how well it works. The goal is to find a safe, effective alternative to daily shots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS3-007a (oral dry suspension)
- What this could lead to
- If successful, this could offer a needle-free alternative to daily growth hormone injections for children with growth hormone deficiency.
- What could go wrong
- This is an early-phase trial with only 88 participants. The oral treatment may not work as well as injections, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2026
- Expected to finish
-
Nov 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * chronological age (CA) ≥3 years at Screening * Prepubertal girls or boys * Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD) * A confirmed diagnosis of growth hormone deficiency (GHD) * Having not been treated with any growth-promoting drugs * BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period) * Subjects who have completed the 52-week treatment period of phase II * Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II Exclusion Criteria: * A highly allergic constitution * Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH * Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth * Congenital skeletal dysplasia or serious spinal anomalies * Cognitive hypofunction, neurodevelopmental disorders, or psychiatric/psychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints * Any clinically significant abnormality that may affect growth or evaluation of the IMP * Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth * Concurrent use of any medications that may affect growth or response to growth hormone therapy * Epiphyseal closure * Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged * Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period) * Subjects with closed epiphyses * Any clinically significant abnormality that may affect growth or evaluation of the IMP * Known or suspected allergy to the IMP * Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pediatric growth hormone deficiency are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.