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Once-weekly inpegsomatropin versus daily growth hormone for children born small for gestational age

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）

Phase 3 Interventional Xiamen Amoytop Biotech Co., Ltd. · NCT07309562

This trial will test whether once-weekly inpegsomatropin helps children born small for gestational age grow as well as daily recombinant human growth hormone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment141 (estimated)
Ages2 Years to 11 Years
SexAll
SponsorXiamen Amoytop Biotech Co., Ltd. Industry-sponsored
Locations49 sites (Beijing and 48 other locations)
Trial IDNCT07309562 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open-label, active-controlled Phase 3 trial enrolling 141 prepubertal children born small for gestational age with short stature. Participants are stratified by sex and age and randomized 1:1:1 into two experimental inpegsomatropin groups or an active control group receiving daily recombinant human growth hormone. After up to 12 weeks of screening, children receive 52 weeks of treatment followed by a 5-week post-treatment follow-up. Efficacy (growth outcomes) and safety (adverse events, labs) will be systematically collected and compared between the weekly and daily treatment arms.

Who should consider this trial

Good fit: Ideal candidates are prepubertal children (Tanner stage I) born SGA who are aged ≥2 to <11 years for boys or ≥2 to <10 years for girls, have height below −2 SD, bone age within −2 to +1 years of chronological age, gestational age ≥28 weeks, BMI between the 5th and 95th percentiles, a peak GH ≥10 ng/mL on at least one prior stimulation test, and no prior continuous systemic growth-promoting therapy.

Not a fit: Children who are already in puberty, have prior prolonged growth-promoting therapy, have bone age or BMI outside the study ranges, were born before 28 weeks gestation, or have known GH deficiency or other causes of short stature outside SGA may not be eligible or likely to benefit from the regimen tested here.

Why it matters

Potential benefit: If successful, the drug could provide comparable height gains with once-weekly injections, reducing the burden of daily injections for children and families.

How similar studies have performed: Other long-acting growth hormone formulations have shown in clinical trials that weekly dosing can produce growth and safety outcomes comparable to daily GH, so the general approach has supportive precedent.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Beijing and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small for Gestational AgeInpegsomatropin InjectionRecombinant Human Growth Hormone Injection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.