Inpegsomatropin once-weekly injection evaluated for efficacy, safety in children with SGA short stature

Short stature born small for gestational age (SGA) affects children whose birth weight or length is below the 10th percentile, often leading to persistent short stature if catch-up growth doesn't occur by age 2-4. Recombinant human growth hormone (rhGH) is an established treatment, but its daily injection regimen can lead to poor adherence and significant burden for children and families. A long-acting growth hormone formulation like Inpegsomatropin, requiring less frequent administration, could significantly improve treatment convenience and patient compliance, addressing a critical gap in current therapeutic approaches for this population.

This multicenter, randomized, open-label, active-controlled Phase III clinical trial plans to enroll 141 children with short stature born SGA. Participants will be stratified by gender and age, then randomized in a 1:1:1 ratio to receive either Inpegsomatropin (two experimental groups) or recombinant human growth hormone (rhGH). The study includes a screening period (up to 12 weeks), a 52-week treatment period, and a 5-week post-treatment follow-up. Primary endpoints will comprehensively evaluate efficacy and safety.

This Phase III clinical trial is currently ongoing, and specific efficacy and safety results are not yet available. The study aims to compare the growth velocity, safety profile, and tolerability of once-weekly Inpegsomatropin against daily recombinant human growth hormone in children with short stature born SGA. Data collection and analysis are underway, and findings regarding improvements in height velocity, changes in height standard deviation score (SDS), and incidence of adverse events will be reported upon completion of the 52-week treatment period.