The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
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 Short Stature Born Small for Gestational Age（SGA）
1 other identifier
interventional
141
1 country
48
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2026
48 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
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedStudy Start
First participant enrolled
January 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 7, 2028
March 2, 2026
February 1, 2026
2.1 years
December 15, 2025
February 26, 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
Ratio of the change in bone age to the change in chronological age
Week 52
Study Arms (3)
Experimental Group 1
EXPERIMENTALExperimental Group 2
EXPERIMENTALrhGH group
ACTIVE COMPARATORInterventions
Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
Eligibility Criteria
You may qualify if:
- Prepubertal (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening.
- 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.
You may not qualify if:
- Subjects with closed epiphyses.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
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
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
December 15, 2025
First Posted
December 30, 2025
Study Start
January 20, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
May 7, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share