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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Children's Hospital, Capital Medical University
  Beijing, China Recruiting
• Beijing Children's Hospital, Capital Medical University
  Beijing, China Recruiting
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• The First Hospital of Jilin University
  Changchun, China Recruiting
• Hunan Children's Hospital
  Changsha, China Recruiting
• Chengdu Women's and Children's Central Hospital
  Chengdu, China Recruiting

Study contacts

• Principal investigator: Xiaoping Luo, Ph.D — Tongji Hospital
• Study coordinator: Xiaoping Luo, Ph.D
• Email: xpluo@tjh.tjmu.edu.cn
• Phone: 15671671188

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.