Idiopathic Short StatureNCT07894341
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
A study testing Inpegsomatropin Injection in people with Idiopathic Short Stature, run by Xiamen Amoytop Biotech Co., Ltd. at 27 sites in China.
Trial summary
This study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have completed Phase Ⅲ clinical trials. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Idiopathic Short Stature
- What is being tested?
- Inpegsomatropin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 27 sitesChina
- Study dates
- 26 Sep 2026to 30 Jun 2042
- Phase
- Interventional
- 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants previously enrolled in the ISS Phase III clinical study (Study Number: PEGPESEN-4-2-001) with good treatment compliance (80%-120%), for whom the investigator assesses that the benefit of continuing growth hormone therapy outweighs the risk, and who enter this extension study within 4 weeks after completion of the Phase III study.
- Legal guardians understand and provide signed informed consent. Participants aged ≥ 8 years shall also provide signed informed consent. For participants under 8 years of age who are capable of expressing assent, their assent shall be explicitly documented.
Who cannot join
- Participants have received other growth-promoting therapies other than those specified in the protocol within 2 months prior to entry into this extension study, including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
- Evidence of closed epiphyseal growth plates or achievement of near-adult height (defined as calculated HV < 2 cm/year over at least 6 months, or bone age ≥ 16 years for males, bone age ≥ 14 years for females).
- Other conditions under which, in the investigator's opinion, continuation in this extension study is inappropriate.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Capital Institute of Pediatrics, Beijing (SHOUER)
Beijing
Fuying Song
- Recruiting
Hunan Children's Hospital
Changsha
Yan Zhong
- Recruiting
Chengdu Women's and Children's Central Hospital
Chengdu
Xinran Cheng
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu
Fan Yang
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Liyang Liang
- Recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou
Shunye Zhu
- Recruiting
Anhui Provincial Children's Hospital
Hefei
Yuqing Chen
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
Deyun Liu
- Recruiting
Jiaxing First Hospital
Jiaxing
Shunfeng Mao
- Recruiting
Affiliated Hospital of Jining Medical University
Jining
Meiyun Xin
- Recruiting
Kunming Children's Hospital
Kunming
Na Tao
- Recruiting
Gansu Provincial Maternity and Child Care Hospital
Lanzhou
Bo Sun
- Recruiting
Jiangxi Provincial Children's Hospital
Nanchang
Yu Yang
- Recruiting
Nanjing Children's Hospital
Nanjing
Wei Gu
- Recruiting
The Affiliated Women's and Children's Hospital of Ningbo University
Ningbo
Shuxia Ding
- Recruiting
Children's Hospital of Shanghai
Shanghai
Pin Li
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Wenli Lu
- Recruiting
Shanghai Children's Medical Center
Shanghai
Xiumin Wang
Yu Ding
- Recruiting
Children's Hospital Affiliated to Soochow University
Suzhou
Haiying Wu
- 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
- Recruiting
Wuhan Children's Hospital
Wuhan
Hui Yao
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Erdi Xu
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Qun Lian
- Recruiting
Xiangyang Central Hospital
Xiangyang
Rui Pan
- 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, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
This study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have completed Phase Ⅲ clinical trials.
Upon completion of the Phase Ⅲ clinical study, participants may enter the extension-phase baseline assessment period after the participant and their guardian provide informed consent, based on the willingness of the participant and guardian as well as the investigator's comprehensive assessment of the benefit-risk profile for the participant's continued participation in this study. Participants who meet all inclusion criteria and do not meet any exclusion criteria will proceed to the extension-phase treatment period to receive continued treatment with Inpegsomatropin Injection. Upon completion of the treatment period, participants will enter the final-height follow-up period, during which growth and development status, medication exposure and safety will be followed up via outpatient visits. This study aims to observe the long-term safety and efficacy of the investigational product.
- Conditions
- Idiopathic Short Stature
- Being tested
- Inpegsomatropin Injection
- Keywords
- Inpegsomatropin Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpegsomatropin InjectionDrug
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly,treatment is continued until participants reach near-adult height.
| Study group | Role | What they receive |
|---|---|---|
| Inpegsomatropin-Injection Group | Experimental | Not described Receives: Drug: Inpegsomatropin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Assessments include vital signs, physical examinations, laboratory tests, and Imaging studies.
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Secondary outcomes (6)
Change in height standard deviation score (ΔHT-SDS)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Height velocity (HV)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in height velocity (ΔHV)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in insulin-like growth factor-1 standard deviation score (ΔIGF-1-SDS)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Ratio of change in bone age to change in chronological age (ΔBA/ΔCA)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Final height (FH)
Measured: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Sep 2026
- Primary completion31 Aug 2041 (estimated)
- Study completion30 Jun 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Short StatureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT07894341
- Sponsor's protocol ID
- PEGPESEN-4-2-003
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
- ClinicalTrials.gov ID
- NCT07894341
- Acronym / sponsor ID
- PEGPESEN-4-2-003
- Conditions
- Idiopathic Short Stature
- Keywords
- Inpegsomatropin Injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2026 (actual)
- Primary completion
- 31 Aug 2041 (estimated)
- Study completion
- 30 Jun 2042 (estimated)
- First posted
- 26 Oct 2026 (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 study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have completed Phase Ⅲ clinical trials.
Upon completion of the Phase Ⅲ clinical study, participants may enter the extension-phase baseline assessment period after the participant and their guardian provide informed consent, based on the willingness of the participant and guardian as well as the investigator's comprehensive assessment of the benefit-risk profile for the participant's continued participation in this study. Participants who meet all inclusion criteria and do not meet any exclusion criteria will proceed to the extension-phase treatment period to receive continued treatment with Inpegsomatropin Injection. Upon completion of the treatment period, participants will enter the final-height follow-up period, during which growth and development status, medication exposure and safety will be followed up via outpatient visits. This study aims to observe the long-term safety and efficacy of the investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpegsomatropin-Injection Group | Experimental | Drug: Inpegsomatropin Injection |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants previously enrolled in the ISS Phase III clinical study (Study Number: PEGPESEN-4-2-001) with good treatment compliance (80%-120%), for whom the investigator assesses that the benefit of continuing growth hormone therapy outweighs the risk, and who enter this extension study within 4 weeks after completion of the Phase III study.
- Legal guardians understand and provide signed informed consent. Participants aged ≥ 8 years shall also provide signed informed consent. For participants under 8 years of age who are capable of expressing assent, their assent shall be explicitly documented.
Key exclusion criteria (3 listed)
- Participants have received other growth-promoting therapies other than those specified in the protocol within 2 months prior to entry into this extension study, including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
- Evidence of closed epiphyseal growth plates or achievement of near-adult height (defined as calculated HV < 2 cm/year over at least 6 months, or bone age ≥ 16 years for males, bone age ≥ 14 years for females).
- Other conditions under which, in the investigator's opinion, continuation in this extension study is inappropriate.
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, 280 μg/kg/week, s.c., once weekly,treatment is continued until participants reach near-adult height. | Drug | Inpegsomatropin-Injection Group |
Primary outcome
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Assessments include vital signs, physical examinations, laboratory tests, and Imaging studies.
6 secondary outcomes
Change in height standard deviation score (ΔHT-SDS)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Height velocity (HV)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in height velocity (ΔHV)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Change in insulin-like growth factor-1 standard deviation score (ΔIGF-1-SDS)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Ratio of change in bone age to change in chronological age (ΔBA/ΔCA)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
Final height (FH)
Time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpegsomatropin Injection in people with Idiopathic Short Stature, run by Xiamen Amoytop Biotech Co., Ltd. at 27 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 2 inclusion and 3 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
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?
Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results. (time frame: Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)). 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 26 Oct 2026.