The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Idiopathic Short Stature (ISS).
1 other identifier
interventional
300
1 country
38
Brief Summary
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 idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2025
Typical duration for phase_3
38 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
April 6, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
April 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedMarch 11, 2026
March 1, 2026
10 months
April 6, 2025
March 10, 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 growth 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
The ratio of the change in bone age to the change in chronological age (△BA/△CA)
From baseline to all follow-up time points at Week 52
Study Arms (2)
Inpegsomatropin group
EXPERIMENTALrhGH group
ACTIVE COMPARATORInterventions
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks.
Recombinant Human Growth Hormone Injection, 350 μg/kg/week, s.c., divided into 7 doses, i.e., 50 μg/kg/day (0.15 IU/kg/day), once daily for 52 consecutive weeks.
Eligibility Criteria
You may qualify if:
- Prepubertal children: boys aged ≥3 years and \<11 years at screening with testicular volume \<4 mL; girls aged ≥3 years and \<10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.
- Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
- Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.
- Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.
- Peak GH level ≥10.0 ng/ml in at least one GH stimulation test.
- No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
- The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented.
You may not qualify if:
- Individuals with closed epiphyses;
- Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;
- Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;
- Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;
- Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.;
- Individuals with abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal, Cr \> upper limit of normal);
- Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol/L on two consecutive occasions;
- Individuals with chronic infectious diseases, such as chronic hepatitis B;
- Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator;
- Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis;
- Individuals with a history of increased intracranial pressure;
- Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors;
- Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients;
- Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Amoytop Biotech Co., Ltd.lead
- Tongji Hospitalcollaborator
Study Sites (38)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Institute of Pediatrics, Beijing (SHOUER)
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
The Affiliated Women's and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Sanya Central Hospital
Hainan, China
Hangzhou First People's Hospital
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, China
Jiaxing First Hospital
Jiaxing, China
Affiliated Hospital of Jining Medical University
Jining, China
Kunming Children's Hospital
Kunming, China
Nanjing Children's Hospital
Nanjing, China
Qingdao Women and Children's Hospital
Qingdao, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
Renmin Hospital of Wuhan University
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiangyang Central Hospital
Xiangyang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Yuncheng Central Hospital
Yuncheng, China
Zhuzhou Central Hospital
Zhuzhou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoping Luo, Ph.D
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
April 6, 2025
First Posted
April 15, 2025
Study Start
April 28, 2025
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 1, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share