Phase III Study of Weekly Inpegsomatropin Injection Compared to Daily Recombinant Human Growth Hormone in Children Aged 2 to 11 Years with Short Stature Born Small for Gestational Age

What this Trial Is About

Researchers are studying children with short stature who were born small for gestational age SGA to evaluate the safety and effectiveness of Inpegsomatropin injection compared with recombinant human growth hormone rhGH. This Phase III, multicenter, randomized clinical trial aims to better understand treatment options for growth challenges in this specific group of children aged 2 to under 11 years. Participants are divided into groups based on age and gender and randomized to receive different treatments or standard care. The trial includes three groups two experimental groups receiving different doses of Inpegsomatropin injection 140 mcgkgweek or 280 mcgkgweek, administered subcutaneously once a week for 52 weeks, and an active control group receiving recombinant human growth hormone injection at 0.033 mgkgday, administered subcutaneously once daily for 52 weeks. Before treatment, participants undergo a screening period lasting up to 12 weeks. After the 52-week treatment, there is a 5-week post-treatment follow-up to monitor safety and efficacy. Participants will be closely monitored throughout the study with regular assessments of growth velocity, changes in height, bone age, and insulin-like growth factor 1 levels. Safety evaluations will include checking liver and kidney function and monitoring for adverse effects. The main outcome measured is growth velocity after 52 weeks of treatment. The total time involvement for each participant includes screening, treatment, and follow-up periods, ensuring comprehensive evaluation of treatment impact and safety.

The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age