ELEVATEThe Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)

This study aims to explore how well a new treatment, PEG-somatropin (GenSci004), works for children who have growth hormone deficiency (GHD) and have not received any prior treatment. The focus is on prepubertal children, meaning those who have not yet gone through puberty, who experience growth failure due to this condition. The research is important because it compares a weekly treatment to the more common daily treatment, potentially offering a more convenient option for children and their families if it proves to be as effective and safe. Participants in the study receive the new treatment, GenSci004, once a week, while others receive the existing daily treatment, Genotropin, for a year. The study is designed to measure how effective and safe the weekly treatment is compared to the daily one. Researchers are looking at how well the children grow and how their bodies tolerate the treatments. This includes monitoring for any potential side effects to ensure the new treatment is not only effective but also safe for young patients.