Phase III Study Comparing Inpegsomatropin and Givopegsomatropin Injections for Treating Short Stature in Girls with Turner Syndrome Aged 2 to 12 Years

What this Trial Is About

The trial is a multicenter, randomized, open-label, positive-controlled phase III study enrolling 84 girls aged 2 to under 12 years with short stature due to Turner Syndrome TS. The study aims to compare the effectiveness and safety of two growth hormone treatments, Inpegsomatropin-Injection and Givopegsomatropin Solution Injection, to provide evidence supporting the new use of Inpegsomatropin in this population. Participants are randomly assigned in equal numbers to receive either Inpegsomatropin injection at 280 mcgkgweek or Givopegsomatropin solution injection at 200 mcgkgweek. Both treatments are administered subcutaneously once a week for 52 weeks. The study follows a parallel design to assess the comparative outcomes of these two drugs throughout the treatment period. During the study, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and bone age progression. Safety and efficacy will be evaluated at various follow-up points up to week 52. Guardians and participants aged 8 or older will provide informed consent or assent. The total participation time covers the full 52-week treatment and assessment period.

The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature