Peer-reviewed article
Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data.
Sävendahl L, Maniatis AK, Pietropoli A, Kelepouris N, Højby M et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study compared somapacitan, a once-weekly growth hormone treatment, with daily growth hormone injections in children with growth hormone deficiency. Using data from three randomised trials involving hundreds of children followed for up to 3 years, the researchers found that both treatments produced similar growth rates and safety profiles. Children who switched from daily injections to weekly injections showed equally good growth outcomes, and the weekly treatment remained effective even after children entered puberty.
Key points
- Height velocity at 52 weeks was similar between somapacitan and daily GH groups
- At 156 weeks, mean height velocity was 7.5-7.8 cm/year across all treatment groups, with no significant differences
- Most adverse events were mild and unlikely to be treatment-related in both groups
- Children who switched from daily to weekly treatment at 52 weeks showed maintained growth rates
- Growth remained stable for up to 130 weeks in children who entered puberty during the study
Limitations
The document does not specify which countries the trials were conducted in or provide demographic details about the study population. The pooled analysis combines data from multiple trials but does not discuss potential heterogeneity in study populations or protocols across the three trials.
Abstract
Introduction Several 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. Methods Participants 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. Results At 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. Conclusions In 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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Somapacitan (once-weekly growth hormone) compared with daily growth hormone injections
- Population
- Children with growth hormone deficiency enrolled in REAL 3, REAL 4, and REAL 6 randomised trials
Key finding
At week 52, height velocity was similar in somapacitan and daily GH groups
L et al. · Europe PMC · 25 Jun 2026