This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.
Prepubertal (Tanner stage I) children: boys aged ≥2 and <11 years, and girls aged ≥2 and <10 years at screening.
Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.
Gestational age at birth ≥28 weeks.
Subjects with closed epiphyses.
Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism.
Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.
Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening.
Parallel
Inpegsomatropin Injection
DrugInpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
Inpegsomatropin Injection
DrugInpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Recombinant Human Growth Hormone Injection
DrugRecombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.
Growth velocity (HV, cm/year).
Change in height standard deviation score from baseline (△HT SDS)
Change in growth velocity from baseline (△HV)
Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)
Ratio of the change in bone age to the change in chronological age
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