Actively Recruiting
Efficacy and Safety of Inpegsomatropin Injection Compared With Recombinant Human Growth Hormone in Children With Idiopathic Short Stature
Led by Xiamen Amoytop Biotech Co., Ltd. · Updated on 2026-03-11
300
Participants Needed
38
Research Sites
117 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
Researchers are evaluating the effectiveness and safety of Inpegsomatropin injection compared to recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). This multicenter, randomized, open-label Phase III trial aims to enroll 300 children with ISS, assessing growth outcomes and safety over a defined period. Participants will be randomly assigned to receive either Inpegsomatropin injection once weekly at 280 micrograms per kilogram or recombinant human growth hormone injection daily at 350 micrograms per kilogram divided into seven doses. The study includes a screening period of up to 12 weeks, followed by a 52-week treatment period and a 5-week post-treatment follow-up. During the trial, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and the ratio of bone age to chronological age. Safety evaluations will also be conducted throughout the study, with the total participation lasting approximately 69 weeks including all phases.
CONDITIONS
Brief Title
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prepubertal boys aged 3 to under 11 years with testicular volume less than 4 mL and girls aged 3 to under 10 years with no breast development beyond Tanner Stage I
- Bone age within 1 year advanced to 2 years delayed compared to chronological age
- Height below -2 standard deviations for age and sex
- Body mass index between the 5th and 95th percentile for age and sex
- Peak growth hormone level at least 10.0 ng/ml in one stimulation test
- No prior continuous pharmacological treatment for growth promotion for 1 month or more
- Legal guardian consent obtained; participants 8 years or older must also consent, with assent documented for younger participants able to express it
You will not qualify if you...
- Closed epiphyses
- Growth abnormalities with known causes such as growth hormone deficiency, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, SHOX gene abnormalities, malnutrition, hypothyroidism
- Participation in another clinical trial within 3 months before screening
- Recent use of corticosteroids exceeding specified durations
- Current or required long-term treatment with therapies affecting growth such as methylphenidate or sex hormones
- Abnormal liver or kidney function
- Diabetes or elevated fasting blood glucose
- Chronic infections like hepatitis B
- Systemic chronic diseases including moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular or psychiatric disorders
- Congenital skeletal abnormalities, scoliosis over 15 degrees, limping, history of slipped capital femoral epiphysis
- History of increased intracranial pressure
- History or presence of malignancy
- Severe allergies or known allergies to growth hormone or its components
- Any other condition deemed unsafe or affecting compliance by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive weekly injections of either Inpegsomatropin or recombinant human growth hormone for 52 consecutive weeks.
Weekly visits for injections
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
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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