The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.
1 other identifier
interventional
84
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2026
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 29, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2030
June 2, 2026
May 1, 2026
1.8 years
May 21, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth velocity (HV, cm/year).
Week 52
Secondary Outcomes (4)
Change in height standard deviation score from baseline (△HT SDS)
From baseline to all follow-up time points at Week 52
Change in height velocity from baseline (△HV)
From baseline to all follow-up time points at Week 52
Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)
From baseline to all follow-up time points at Week 52
Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)
Week 52
Study Arms (2)
Inpegsomatropin Injection Group
EXPERIMENTALGivopegsomatropin Solution Injection Group
ACTIVE COMPARATORInterventions
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Anyang Maternal and Child Health Hospital
Anyang, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Capital Institute of Pediatrics, Capital Medical University
Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Chengdu Women's and Children's Central Hospital
Chengdu, China
Children's Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, China
The First Affiliated Hospital of Hebei North University
Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, China
Huzhou Central Hospital
Huzhou, China
Jiangxi Provincial Children's Hospital
Jiangxi, China
The First Hospital of Jilin University
Jilin, China
Shandong Provincial Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Kunming Children's Hospital
Kunming, China
Gansu Provincial People's Hospital
Lanzhou, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Pingxiang People's Hospital
Pingxiang, China
Qilu Hospital of Shandong University
Qilu, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Children's Hospital
Shanghai, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Shanxi, China
Shaoxing People's Hospital
Shaoxing, China
Shengjing Hospital of China Medical University
Shenyang, China
Shenzhen Children's Hospital
Shenzhen, China
West China Second University Hospital, Sichuan University
Sichuan, China
Children's Hospital of Soochow University
Suzhou, China
Taizhou First People's Hospital
Taizhou, China
Taizhou People's Hospital
Taizhou, China
Tangshan Maternal and Child Health Hospital
Tangshan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuhan Children's Hospital
Wuhan, China
Affiliated Hospital of Jiangnan University
Wuxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiamen Maternal and Child Health Hospital
Xiamen, China
Xiangyang First People's Hospital
Xiangyang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Yibin Second People's Hospital
Yibin, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, China
Zibo Central Hospital
Zibo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoping Luo
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2026
First Posted
May 29, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
February 28, 2030
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share