The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age

Exclusion Criteria

• •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.
• •Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin.
• •Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal \[ULN\], Cr \> ULN).
• •Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization.
• •Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B).
• •Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders.
• •Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis.
• •History of intracranial hypertension.
• •Past or current history of malignant tumors, including intracranial tumors.
• •Known allergy to growth hormone or any of its excipients.
• •Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.