An interventional study of Inpegsomatropin Injection in Idiopathic Short Stature, sponsored by Xiamen Amoytop Biotech Co., Ltd.. Recruiting at 27 sites in China. Open to participants aged 4 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Xiamen Amoytop Biotech Co., Ltd. · Not applicable, Interventional, and Treatment
This study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have completed Phase Ⅲ clinical trials.
Upon completion of the Phase Ⅲ clinical study, participants may enter the extension-phase baseline assessment period after the participant and their guardian provide informed consent, based on the willingness of the participant and guardian as well as the investigator's comprehensive assessment of the benefit-risk profile for the participant's continued participation in this study. Participants who meet all inclusion criteria and do not meet any exclusion criteria will proceed to the extension-phase treatment period to receive continued treatment with Inpegsomatropin Injection. Upon completion of the treatment period, participants will enter the final-height follow-up period, during which growth and development status, medication exposure and safety will be followed up via outpatient visits. This study aims to observe the long-term safety and efficacy of the investigational product.
Xiamen Amoytop Biotech Co., Ltd. is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly,treatment is continued until participants reach near-adult height.
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Assessments include vital signs, physical examinations, laboratory tests, and Imaging studies.
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in height standard deviation score (ΔHT-SDS)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Height velocity (HV)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in height velocity (ΔHV)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in insulin-like growth factor-1 standard deviation score (ΔIGF-1-SDS)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Ratio of change in bone age to change in chronological age (ΔBA/ΔCA)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Final height (FH)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2041, 179 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Inpegsomatropin
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