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Clinical Trials in China / NCT07614152
Recruiting Phase 3

The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

NCT07614152 · tracked via the Priya Life Science China tracker
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Phase
Phase 3
Started
2026-07-05
Last updated
2026-07-22

Condition(s) studied

Turner Syndrome

Investigational drug(s) / intervention(s)

Inpegsomatropin-InjectionGivopegsomatropin Solution Injection

Inpegsomatropin-Injection: Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.

Givopegsomatropin Solution Injection: Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Study summary

This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.

Eligibility

Sex
FEMALE
Min age
2 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * Prepubertal girls at Tanner stage I, with age ≥ 2 years and \< 12 years at the time of informed consent signature. * With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells). * At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year). * At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1. * No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc. * Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks. * The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented. Exclusion Criteria: * Subjects with closed epiphyses. * Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy. * Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition. * Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received. * Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening. * Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc. * Abnormal liver and renal function at screening (ALT \> 2 times the upper limit of normal; Cr \> upper limit of normal). * Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study. * Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B. * Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders. * Subjects with severe congenital skeletal dysplasia; or those with scoliosis \> 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis. * Subjects with a prior history of intracranial hypertension. * Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors. * Known hypersensitivity to growth hormone or its excipients. * Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening. * Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Anyang Maternal and Child Health Hospital Anyang China Recruiting
Beijing Children's Hospital, Capital Medical University Beijing China Recruiting
Capital Institute of Pediatrics, Capital Medical University Beijing China Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting
Peking University First Hospital Beijing China Recruiting
The Second Xiangya Hospital of Central South University Changsha China Recruiting
Chengdu Women's and Children's Central Hospital Chengdu China Recruiting
Children's Hospital of Chongqing Medical University Chongqing China Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian China Recruiting
Guangdong Provincial Maternal and Child Health Hospital Guangzhou China Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou China Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guangzhou China Recruiting
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou China Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou China Recruiting
Zhejiang Provincial Hospital of Traditional Chinese Medicine Hangzhou China Recruiting
The First Affiliated Hospital of Hebei North University Hebei China Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Henan China Recruiting
Huzhou Central Hospital Huzhou China Recruiting
Jiangxi Provincial Children's Hospital Jiangxi China Recruiting
The First Hospital of Jilin University Jilin City China Recruiting
Shandong Provincial Hospital Jinan China Recruiting
Affiliated Hospital of Jining Medical University Jining China Recruiting
Kunming Children's Hospital Kunming China Recruiting
Gansu Provincial People's Hospital Lanzhou China Recruiting
The Second Affiliated Hospital of Guangxi Medical University Nanning China Recruiting
Pingxiang People's Hospital Pingxiang China Recruiting
Qilu Hospital of Shandong University Qilu China Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Shanghai Children's Hospital Shanghai China Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine Shanxi China Recruiting
Shaoxing People's Hospital Shaoxing China Recruiting
Shengjing Hospital of China Medical University Shenyang China Recruiting
Shenzhen Children's Hospital Shenzhen China Recruiting
West China Second University Hospital, Sichuan University Sichuan China Recruiting
Children's Hospital of Soochow University Suzhou China Recruiting
Taizhou First People's Hospital Taizhou China Recruiting
Taizhou People's Hospital Taizhou China Recruiting
Tangshan Maternal and Child Health Hospital Tangshan China Recruiting

+ 11 more sites — see the full list on the official registry below.

More Xiamen Amoytop Biotech Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614152 on ClinicalTrials.gov ↗ ← All trials in China