The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Trial Parameters
Brief 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 idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
Eligibility Criteria
Inclusion Criteria: * Prepubertal children: boys aged ≥3 years and \<11 years at screening with testicular volume \<4 mL; girls aged ≥3 years and \<10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue. * Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year). * Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1. * Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2. * Peak GH level ≥10.0 ng/ml in at least one GH stimulation test. * No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc. * The legal guardian understands and signs the informed consent form. If