Actively Recruiting
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Led by Xiamen Amoytop Biotech Co., Ltd. · Updated on 2026-03-11
300
Participants Needed
38
Research Sites
161 weeks
Total Duration
On this page
Sponsors
X
Xiamen Amoytop Biotech Co., Ltd.
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
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 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.
CONDITIONS
Official Title
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Boys aged 3 years or older and under 11 years with testicular volume less than 4 mL; girls aged 3 years or older and under 10 years with no palpable breast glandular tissue (Tanner Stage I).
- Bone age must be within 1 year advanced to 2 years delayed compared to chronological age.
- Height at screening below -2 standard deviations from the mean for age and sex.
- Body mass index (BMI) between the 5th and 95th percentile for age and sex.
- Peak growth hormone level of 10.0 ng/ml or higher in at least one stimulation test.
- No prior systemic pharmacological treatment for growth promotion lasting one month or more.
- Legal guardian must understand and sign informed consent; participants 8 years or older must also sign, and younger participants able to express assent must have it documented.
You will not qualify if you...
- Closed epiphyses (growth plates).
- Growth disorders with known causes including growth hormone deficiency, genetic syndromes (Noonan, Prader-Willi, Russell-Silver, Turner), small for gestational age, SHOX gene abnormalities, malnutrition, hypothyroidism, or other clear etiologies.
- Participation in any other clinical trial within 3 months before screening.
- Use of inhaled corticosteroids for more than 2 weeks or oral/IV corticosteroids for more than 1 week within 3 months before screening.
- Current or needed long-term treatments affecting growth (e.g., methylphenidate, sex hormones, GnRH analogs, aromatase inhibitors, anabolic agents, insulin).
- Abnormal liver or kidney function at screening.
- Diabetes mellitus or fasting blood glucose above 6.1 mmol/L on two occasions.
- Chronic infections like hepatitis B.
- Severe systemic chronic diseases including anemia, malnutrition, hypothyroidism, kidney disease, heart disease, psychiatric disorders, or congenital anomalies needing intervention.
- Congenital skeletal abnormalities, scoliosis over 15°, limping, or history of slipped capital femoral epiphysis.
- History of increased intracranial pressure or malignancy.
- Severe allergies or known allergy to growth hormone or its components.
- Any other condition the investigator feels may risk safety or study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Actively Recruiting
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
Capital Institute of Pediatrics, Beijing (SHOUER)
Beijing, Beijing Municipality, China
Actively Recruiting
4
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
6
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu, China
Actively Recruiting
7
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Actively Recruiting
8
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
9
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
10
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Actively Recruiting
11
Wuhan Children's Hospital
Wuhan, Hubei, China
Actively Recruiting
12
Hunan Children's Hospital
Changsha, Hunan, China
Actively Recruiting
13
Children's Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
14
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Actively Recruiting
15
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Actively Recruiting
16
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Actively Recruiting
17
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
18
The Affiliated Women's and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
19
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
20
Sanya Central Hospital
Hainan, China
Actively Recruiting
21
Hangzhou First People's Hospital
Hangzhou, China
Actively Recruiting
22
Zhejiang Provincial People's Hospital
Hangzhou, China
Actively Recruiting
23
The First Affiliated Hospital of Henan University of Science and Technology
Henan, China
Actively Recruiting
24
Jiaxing First Hospital
Jiaxing, China
Actively Recruiting
25
Affiliated Hospital of Jining Medical University
Jining, China
Actively Recruiting
26
Kunming Children's Hospital
Kunming, China
Actively Recruiting
27
Nanjing Children's Hospital
Nanjing, China
Actively Recruiting
28
Qingdao Women and Children's Hospital
Qingdao, China
Actively Recruiting
29
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
30
Shanghai Children's Medical Center
Shanghai, China
Actively Recruiting
31
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
32
The First Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
33
Renmin Hospital of Wuhan University
Wuhan, China
Actively Recruiting
34
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
35
Xiangyang Central Hospital
Xiangyang, China
Actively Recruiting
36
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Actively Recruiting
37
Yuncheng Central Hospital
Yuncheng, China
Actively Recruiting
38
Zhuzhou Central Hospital
Zhuzhou, China
Actively Recruiting
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
2
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