ArticleHormone research in paediatrics2026
Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data.
Article in Hormone research in paediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
introductionSeveral studies have individually suggested that somapacitan, a once-weekly growth hormone (GH) treatment, has similar efficacy and safety to once-daily GH in children with GH deficiency. Here, we assessed the efficacy and safety of somapacitan versus daily GH after 52 and 156 weeks of treatment using pooled data from the REAL 3, REAL 4, and REAL 6 trials.
methodsParticipants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included. Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately. Outcomes, including height velocity (HV) and adverse events (AEs), were analysed by treatment group. An additional analysis was conducted in relation to puberty onset and Tanner stage.
resultsAt week 52, HV was similar in participants receiving somapacitan and those receiving daily GH. At week 156, mean (SD) HV (cm/year) was 7.5 (1.6) in participants who had always received somapacitan, 7.6 (2.0) in those who had always received daily GH, and 7.8 (1.4) in those who switched to somapacitan from daily GH. Most AEs were mild and unlikely to be treatment-related. HV remained stable for up to 130 weeks in pubertal children, and was similar across treatment groups and Tanner stages.
conclusionsIn this pooled analysis of clinical trial data, somapacitan demonstrated similar efficacy and safety to daily GH for up to 156 weeks of treatment. A dose of 0.16 mg/kg/week of somapacitan was able to maintain consistent growth in children and adolescents who reached puberty.
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