Inpegsomatropin weekly injection to be evaluated against daily rhGH for idiopathic short stature in Phase III trial

Idiopathic short stature (ISS) is a diagnosis for children whose height is significantly below average without an identifiable medical cause. While not a disease, it can lead to psychosocial challenges. The current standard of care often involves daily subcutaneous injections of recombinant human growth hormone (rhGH), which, despite its effectiveness, imposes a significant burden on children and their families due to the frequent administration. This daily regimen can lead to poor adherence, potentially compromising treatment outcomes. There is a clear clinical need for less frequent, longer-acting growth hormone formulations to improve patient convenience and compliance, thereby enhancing the overall treatment experience and efficacy for children with ISS.

This multicenter, randomized, open-label, active-controlled Phase III trial evaluates Inpegsomatropin injection, administered once a week, against daily recombinant human growth hormone (rhGH) for efficacy and safety in children with idiopathic short stature (ISS). The study will enroll 300 children with ISS, randomized and stratified by gender/age. Participants will undergo a screening period (up to 12 weeks), a treatment period of 52 weeks, and a post-treatment follow-up of 5 weeks. Efficacy (e.g., height velocity) and safety are the primary endpoints.