Somapacitan effective and safe for children with Growth Hormone deficiency, finds a Study
Somapacitan was found to be effective and safe compared to growth hormone in growth hormone deficient children as per a recent study that was published in the Journal of Clinical Endocrinology and Metabolism.
Growth deficiency can occur at different ages, depending on various mechanisms like hormonal deficiency or genetic conditions, or idiopathic. Somapacitan is a reversible albumin-binding GH derivative. It is given at a once-weekly dosage. Recently researchers evaluated the efficacy and safety of the drug Somapacitan in children with GH deficiency (GHD) in comparison with growth hormone.
A randomized, multi-national, open-labeled, active-controlled parallel-group phase 3 trial called the REAL4 trial was done at eighty-six sites across 20 countries. REAL4 comprised a 52-week main trial and a three-year extension. 200 treatment-naïve participants were randomized 2:1 to somapacitan at 0.16 mg/kg/week or daily GH at 0.034 mg/kg/day, administered subcutaneously. Norditropin® was the GH that was given to the participants. The primary endpoint was annualized height velocity (HV; cm/year) at week 52. Additional assessments included HV standard deviation score (SDS), height SDS, bone age, IGF-I SDS, patient-reported outcomes, and safety measures.
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