Small for Gestational AgePhase 3NCT07309562
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
A Phase 3 study testing Inpegsomatropin Injection and Recombinant Human Growth Hormone Injection in people with Small for Gestational Age, run by Xiamen Amoytop Biotech Co., Ltd. at 49 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Small for Gestational Age
- What is being tested?
- Inpegsomatropin Injection and Recombinant Human Growth Hormone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 49 sitesChina
- Study dates
- 20 Jan 2026to 7 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
49 sites in 1 country. Contact the study team or a site near you to ask about taking part.
49 sites in 1 country
China49 sites, 49 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Bingyan Cao
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Di Wu
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
Mingsheng Ma
- Recruiting
The First Hospital of Jilin University
Changchun
Yining Zhang
- Recruiting
Hunan Children's Hospital
Changsha
Sha Zhao
- Recruiting
Chengdu Women's and Children's Central Hospital
Chengdu
Xinran Cheng
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu
Fan Yang
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
Min Zhu
- Recruiting
Fuzhou First General Hospital
Fuzhou
Yanqin Ying
- Recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou
Wen Zhang
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Liyang Liang
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
Qiuli Chen
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Shunye Zhu
- Recruiting
Hainan Women and Children's Medical Center
Haikou
Xiaoyan Huang
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Chunlin Wang
- Recruiting
Heilongjiang Provincial Hospital
Harbin
Pu Zhao
- Recruiting
Anhui Children's Hospital
Hefei
Yuqing Chen
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
Deyun Liu
- Recruiting
Inner Mongolia People's Hospital
Hohhot
Hua Zhu
- Recruiting
Shandong Provincial Hospital
Jinan
Yan Sun
- Recruiting
Affiliated Hospital of Jining Medical University
Jining
Mei Zhang
- Recruiting
Jiujiang Maternal and Child Health Hospital
Jiujiang
Huayan Hu
- Recruiting
Kunming Children's Hospital
Kunming
Na Tao
- Recruiting
Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital)
Lanzhou
Bo Sun
- Recruiting
Liuzhou People's Hospital
Liuzhou
Ling Jin
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Dan Lou
- Recruiting
Jiangxi Provincial Children's Hospital
Nanchang
Yu Yang
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Yang Liu
- Recruiting
Nanjing Children's Hospital
Nanjing
Wei Gu
- Recruiting
Ningbo Women and Children's Hospital, Ningbo University
Ningbo
Shuxia Ding
- Recruiting
Qujing Maternal and Child Health Hospital
Qujing
Hongyan Zhu
- Recruiting
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya
Hua Zhang
- Recruiting
Shanghai Children's Hospital
Shanghai
Pin Li
- Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai
Guoying Chang
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Lili Liang
- Recruiting
Shengjing Hospital of China Medical University
Shenyang
Ying Xin
- Recruiting
Children's Hospital of Soochow University
Suzhou
Rongrong Xie
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Rongxiu Zheng
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Maimaiti Mireguli
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Xiaoou Shan
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xiaoping Luo, Ph.D, 15671671188, xpluo@tjh.tjmu.edu.cn
- Recruiting
Wuhan Children's Hospital
Wuhan
Hui Yao
- Recruiting
Wuxi Children's Hospital
Wuxi
Lulian Xu
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Qun Lian
- Recruiting
Xiamen Maternal and Child Health Hospital
Xiamen
Xiaoqing Yang
- Recruiting
Xuzhou Children's Hospital
Xuzhou
Ying Xue
- Recruiting
Yuncheng Central Hospital, Shanxi Province
Yuncheng
Yuenv Sun
- Recruiting
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou
Haiyan Wei
- Recruiting
Zhuzhou Central Hospital
Zhuzhou
Xianglan Wen
About this study
Official title: 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）
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.
- Conditions
- Small for Gestational Age
- Being tested
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Keywords
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpegsomatropin InjectionDrug
Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Inpegsomatropin InjectionDrug
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Recombinant Human Growth Hormone InjectionDrug
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Not described Receives: Drug: Inpegsomatropin Injection |
| Experimental Group 2 | Experimental | Not described Receives: Drug: Inpegsomatropin Injection |
| rhGH group | Active comparator | Not described Receives: Drug: Recombinant Human Growth Hormone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity (HV, cm/year).
Measured: Week 52
Secondary outcomes (4)
Change in height standard deviation score from baseline (△HT SDS)
Measured: From baseline to all follow-up time points at Week 52
Change in growth velocity from baseline (△HV)
Measured: 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)
Measured: From baseline to all follow-up time points at Week 52
Ratio of the change in bone age to the change in chronological age
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completion7 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational AgeStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoping Luo, Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309562
- Sponsor's protocol ID
- PEGPESEN-4-2-002
- Status last verified
- May 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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）
- ClinicalTrials.gov ID
- NCT07309562
- Acronym / sponsor ID
- PEGPESEN-4-2-002
- Conditions
- Small for Gestational Age
- Keywords
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 7 May 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: Inpegsomatropin Injection |
| Experimental Group 2 | Experimental | Drug: Inpegsomatropin Injection |
| rhGH group | Active comparator | Drug: Recombinant Human Growth Hormone Injection |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpegsomatropin InjectionInpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks. | Drug | Experimental Group 1 |
| Inpegsomatropin InjectionInpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks. | Drug | Experimental Group 2 |
| Recombinant Human Growth Hormone InjectionRecombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks. | Drug | rhGH group |
Primary outcome
Growth velocity (HV, cm/year).
Time frame: Week 52
4 secondary outcomes
Change in height standard deviation score from baseline (△HT SDS)
Time frame: From baseline to all follow-up time points at Week 52
Change in growth velocity from baseline (△HV)
Time frame: 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)
Time frame: From baseline to all follow-up time points at Week 52
Ratio of the change in bone age to the change in chronological age
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Small for Gestational Age
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Turner Syndrome, Short Stature Homeobox Gene Mutation
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Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
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Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoping Luo, Ph.D principal investigator
Tongji Hospital
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inpegsomatropin Injection and Recombinant Human Growth Hormone Injection in people with Small for Gestational Age, run by Xiamen Amoytop Biotech Co., Ltd. at 49 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Luo, Ph.D (15671671188, xpluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity (HV, cm/year). (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.