NCT06927310 The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
| NCT ID | NCT06927310 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xiamen Amoytop Biotech Co., Ltd. |
| Condition | Idiopathic Short Stature |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-04-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
Eligibility Criteria
Inclusion Criteria: * Prepubertal children: boys aged ≥3 years and \<11 years at screening with testicular volume \<4 mL; girls aged ≥3 years and \<10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue. * Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year). * Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1. * Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2. * Peak GH level ≥10.0 ng/ml in at least one GH stimulation test. * No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc. * The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented. Exclusion Criteria: * Individuals with closed epiphyses; * Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities; * Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions; * Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening; * Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.; * Individuals with abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal, Cr \> upper limit of normal); * Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol/L on two consecutive occasions; * Individuals with chronic infectious diseases, such as chronic hepatitis B; * Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator; * Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis; * Individuals with a history of increased intracranial pressure; * Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors; * Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients; * Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.
Contact & Investigator
Xiaoping Luo, Ph.D
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT06927310 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 11 Years, studying Idiopathic Short Stature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06927310 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06927310 currently recruiting?
Yes, NCT06927310 is actively recruiting participants. Contact the research team at xpluo@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT06927310 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT06927310 clinical trial?
NCT06927310 is sponsored by Xiamen Amoytop Biotech Co., Ltd.. The principal investigator is Xiaoping Luo, Ph.D at Tongji Hospital. The trial plans to enroll 300 participants.