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The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Led by Xiamen Amoytop Biotech Co., Ltd. · Updated on 2026-05-08
141
Participants Needed
49
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.
CONDITIONS
Official Title
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prepubertal children: boys aged 62 and <11 years, girls aged 62 and <10 years at screening
- Bone age within 1 year advanced or 2 years delayed compared to chronological age
- Birth weight and/or length below the 10th percentile for gestational age and sex
- Gestational age at birth 62 28 weeks
- Height below -2 standard deviations for age and sex at screening
- Body mass index between 5th and 95th percentiles for age and sex
- Peak growth hormone level 62 10.0 ng/mL in at least one prior stimulation test
- No prior systemic growth-promoting therapy used continuously for 1 month or longer
- Legal guardian has provided written informed consent; written assent for participants 62 8 years old or capable younger children
You will not qualify if you...
- Closed bone growth plates (epiphyses)
- Other growth abnormalities such as growth hormone deficiency, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, GH receptor deficiency, SHOX gene-related short stature, malnutrition, or hypothyroidism
- Participation in another clinical trial within 3 months before screening
- Use of inhaled corticosteroids >2 consecutive weeks or oral/intravenous corticosteroids >1 week within 3 months before screening
- Need for long-term therapies affecting growth like methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin
- Abnormal liver or kidney function at screening
- Diabetes mellitus or high fasting blood glucose before randomization
- Chronic infectious diseases that may affect study participation
- Systemic chronic diseases such as chronic kidney disease, severe cardiovascular diseases, or psychiatric disorders
- Congenital skeletal dysplasia, scoliosis over 15 degrees, limping gait, or slipped capital femoral epiphysis
- History of intracranial hypertension
- Past or current malignant tumors including intracranial tumors
- Known allergy to growth hormone or its components
- Any other condition deemed inappropriate by the investigator for study participation
AI-Screening
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Trial Site Locations
Total: 49 locations
1
Beijing Children's Hospital, Capital Medical University
Beijing, China
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2
Beijing Children's Hospital, Capital Medical University
Beijing, China
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3
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
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4
The First Hospital of Jilin University
Changchun, China
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5
Hunan Children's Hospital
Changsha, China
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6
Chengdu Women's and Children's Central Hospital
Chengdu, China
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7
West China Second University Hospital, Sichuan University
Chengdu, China
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8
Children's Hospital of Chongqing Medical University
Chongqing, China
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9
Fuzhou First General Hospital
Fuzhou, China
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10
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, China
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11
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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12
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
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13
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
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14
Hainan Women and Children's Medical Center
Haikou, China
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15
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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16
Heilongjiang Provincial Hospital
Harbin, China
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17
Anhui Children's Hospital
Hefei, China
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18
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
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19
Inner Mongolia People's Hospital
Hohhot, China
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20
Shandong Provincial Hospital
Jinan, China
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21
Affiliated Hospital of Jining Medical University
Jining, China
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22
Jiujiang Maternal and Child Health Hospital
Jiujiang, China
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23
Kunming Children's Hospital
Kunming, China
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24
Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital)
Lanzhou, China
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25
Liuzhou People's Hospital
Liuzhou, China
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26
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
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27
Jiangxi Provincial Children's Hospital
Nanchang, China
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28
The Second Affiliated Hospital of Nanchang University
Nanchang, China
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29
Nanjing Children's Hospital
Nanjing, China
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30
Ningbo Women and Children's Hospital, Ningbo University
Ningbo, China
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31
Qujing Maternal and Child Health Hospital
Qujing, China
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32
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, China
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33
Shanghai Children's Hospital
Shanghai, China
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34
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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35
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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36
Shengjing Hospital of China Medical University
Shenyang, China
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37
Children's Hospital of Soochow University
Suzhou, China
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38
Tianjin Medical University General Hospital
Tianjin, China
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39
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
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40
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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41
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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42
Wuhan Children's Hospital
Wuhan, China
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43
Wuxi Children's Hospital
Wuxi, China
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44
The First Affiliated Hospital of Xiamen University
Xiamen, China
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45
Xiamen Maternal and Child Health Hospital
Xiamen, China
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46
Xuzhou Children's Hospital
Xuzhou, China
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47
Yuncheng Central Hospital, Shanxi Province
Yuncheng, China
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48
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou, China
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49
Zhuzhou Central Hospital
Zhuzhou, China
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Research Team
X
Xiaoping Luo, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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