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Clinical Trials in China / NCT07309562
Recruiting Phase 3

The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age

NCT07309562 · tracked via the Priya Life Science China tracker
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Phase
Phase 3
Started
2026-01-20
Last updated
2026-05-08

Condition(s) studied

Small for Gestational Age

Investigational drug(s) / intervention(s)

Inpegsomatropin InjectionInpegsomatropin InjectionRecombinant Human Growth Hormone Injection

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.

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Beijing Children's Hospital, Capital Medical University Beijing China Recruiting
Beijing Children's Hospital, Capital Medical University Beijing China Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting
The First Hospital of Jilin University Changchun China Recruiting
Hunan Children's Hospital Changsha China Recruiting
Chengdu Women's and Children's Central Hospital Chengdu China Recruiting
West China Second University Hospital, Sichuan University Chengdu China Recruiting
Children's Hospital of Chongqing Medical University Chongqing China Recruiting
Fuzhou First General Hospital Fuzhou China Recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical University Guangzhou China Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou China Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guangzhou China Recruiting
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou China Recruiting
Hainan Women and Children's Medical Center Haikou China Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou China Recruiting
Heilongjiang Provincial Hospital Harbin China Recruiting
Anhui Children's Hospital Hefei China Recruiting
The Second Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Inner Mongolia People's Hospital Hohhot China Recruiting
Shandong Provincial Hospital Jinan China Recruiting
Affiliated Hospital of Jining Medical University Jining China Recruiting
Jiujiang Maternal and Child Health Hospital Jiujiang China Recruiting
Kunming Children's Hospital Kunming China Recruiting
Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital) Lanzhou China Recruiting
Liuzhou People's Hospital Liuzhou China Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang China Recruiting
Jiangxi Provincial Children's Hospital Nanchang China Recruiting
The Second Affiliated Hospital of Nanchang University Nanchang China Recruiting
Nanjing Children's Hospital Nanjing China Recruiting
Ningbo Women and Children's Hospital, Ningbo University Ningbo China Recruiting
Qujing Maternal and Child Health Hospital Qujing China Recruiting
Sanya Central Hospital (Hainan Third People's Hospital) Sanya China Recruiting
Shanghai Children's Hospital Shanghai China Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Shengjing Hospital of China Medical University Shenyang China Recruiting
Children's Hospital of Soochow University Suzhou China Recruiting
Tianjin Medical University General Hospital Tianjin China Recruiting
The First Affiliated Hospital of Xinjiang Medical University Ürümqi China Recruiting
The Second Affiliated Hospital of Wenzhou Medical University Wenzhou China Recruiting

+ 9 more sites — see the full list on the official registry below.

More Xiamen Amoytop Biotech Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07309562 on ClinicalTrials.gov ↗ ← All trials in China