The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
NCT ID: NCT07309562
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
141 participants
INTERVENTIONAL
2025-12-30
2028-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group 1
Inpegsomatropin Injection
Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Experimental Group 2
Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
rhGH group
Recombinant Human Growth Hormone Injection
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
Interventions
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Inpegsomatropin Injection
Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Recombinant Human Growth Hormone Injection
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
* Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.
* Gestational age at birth ≥28 weeks.
* Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2.
* Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3.
* Peak GH level ≥10.0 ng/mL in at least one prior GH stimulation test.
* No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
* Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent should be formally documented.
Exclusion Criteria
* Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism.
* Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.
* Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening.
* Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin.
* Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal \[ULN\], Cr \> ULN).
* Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization.
* Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B).
* Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders.
* Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis.
* History of intracranial hypertension.
* Past or current history of malignant tumors, including intracranial tumors.
* Known allergy to growth hormone or any of its excipients.
* Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.
2 Years
11 Years
ALL
No
Sponsors
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Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Luo, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Beijing Children's Hospital, Capital Medical University
Beijing, , China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Hunan Children's Hospital
Changsha, , China
Chengdu Women's and Children's Central Hospital
Chengdu, , China
West China Second University Hospital, Sichuan University
Chengdu, , China
Children's Hospital of Chongqing Medical University
Chongqing, , China
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
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
Hainan Women and Children's Medical Center
Haikou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Heilongjiang Provincial Hospital
Harbin, , China
Anhui Children's Hospital
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Inner Mongolia People's Hospital
Hohhot, , China
Shandong Provincial Hospital
Jinan, , China
Affiliated Hospital of Jining Medical University
Jining, , China
Jiujiang Maternal and Child Health Hospital
Jiujiang, , China
Kunming Children's Hospital
Kunming, , China
Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital)
Lanzhou, , China
Liuzhou People's Hospital
Liuchow, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Jiangxi Provincial Children's Hospital
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Nanjing Children's Hospital
Nanjing, , China
Ningbo Women and Children's Hospital, Ningbo University
Ningbo, , China
Qujing Maternal and Child Health Hospital
Qujing, , China
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, , 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
Shengjing Hospital of China Medical University
Shenyang, , China
Children's Hospital of Soochow University
Suzhou, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, , China
The Second 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
Wuxi Children's Hospital
Wuxi, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Xiamen Maternal and Child Health Hospital
Xiamen, , China
Xuzhou Children's Hospital
Xuzhou, , China
Yuncheng Central Hospital, Shanxi Province
Yuncheng, , China
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Bingyan Cao
Role: primary
Di Wu
Role: primary
Mingsheng Ma
Role: primary
Yining Zhang
Role: primary
Sha Zhao
Role: primary
Xinran Cheng
Role: primary
Fan Yang
Role: primary
Min Zhu
Role: primary
Wen Zhang
Role: primary
Liyang Liang
Role: primary
Qiuli Chen
Role: primary
Shunye Zhu
Role: primary
Xiaoyan Huang
Role: primary
Chunlin Wang
Role: primary
Pu Zhao
Role: primary
Yuqing Chen
Role: primary
Deyun Liu
Role: primary
Hua Zhu
Role: primary
Yan Sun
Role: primary
Mei Zhang
Role: primary
Huayan Hu
Role: primary
Na Tao
Role: primary
Bo Sun
Role: primary
Ling Jin
Role: primary
Dan Lou
Role: primary
Yu Yang
Role: primary
Yang Liu
Role: primary
Wei Gu
Role: primary
Shuxia Ding
Role: primary
Hongyan Zhu
Role: primary
Hua Zhang
Role: primary
Pin Li
Role: primary
Guoying Chang
Role: primary
Lili Liang
Role: primary
Ying Xin
Role: primary
Rongrong Xie
Role: primary
Maimaiti Mireguli
Role: primary
Xiaoou Shan
Role: primary
Hui Yao
Role: primary
Xu Xu
Role: primary
Qun Lian
Role: primary
Xiaoqing Yang
Role: primary
Ying Xue
Role: primary
Yuenv Sun
Role: primary
Haiyan Wei
Role: primary
Xianglan Wen
Role: primary
Other Identifiers
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PEGPESEN-4-2-002
Identifier Type: -
Identifier Source: org_study_id
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