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, Ferran JM, Fu J, Mori J, Wabitsch M, Miller BS

Hormone research in paediatrics25 Jun 2026

PMID42348474PMCIDPMC13446877DOI10.1159/000553101PepBankPUB-42348474

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialEfficacy outcome
In children with GH deficiency, pooled trial data showed similar height velocity with somapacitan and daily GH at week 52.
In plain wordsIn children with GH deficiency, height velocity at week 52 was similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
No significant changeHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.034 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 52 weeksAs given in this study (human).
Source sentences
Summary
At week 52, HV was similar in participants receiving somapacitan and those receiving daily GH.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
Participants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included.
Summary · context
Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately.
Report a problemFND-4234847401
02HumanNon-randomized trialEfficacy outcome
In children with GH deficiency, week 156 height velocity was 7.5 cm/year with continuous somapacitan versus 7.6 with continuous daily GH.
In plain wordsIn children with GH deficiency, growth velocity was numerically lower with continuous somapacitan than continuous daily GH at week 156.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 156, continuous somapacitan
Study
n: not reported in source
Comparator
Continuous daily GH 0.034 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 156 weeksAs given in this study (human).
Measurements
Height velocity
7.5 cm/year
continuous somapacitan
SD
1.6 cm/year
continuous somapacitan
Height velocity
7.6 cm/year
continuous daily GH
SD
2 cm/year
continuous daily GH
Source sentences
Summary
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.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
Participants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included.
Summary · context
Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately.
Report a problemFND-4234847402
03HumanNon-randomized trialEfficacy outcome
In children with GH deficiency, week 156 height velocity was 7.8 cm/year after switching to somapacitan versus 7.6 with continuous daily GH.
In plain wordsIn children with GH deficiency, growth velocity was numerically higher after switching to somapacitan than continuous daily GH at week 156.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity at week 156, switched to somapacitan
Study
n: not reported in source
Comparator
Continuous daily GH 0.034 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Height velocity
7.8 cm/year
switched to somapacitan
SD
1.4 cm/year
switched to somapacitan
Height velocity
7.6 cm/year
continuous daily GH
SD
2 cm/year
continuous daily GH
Source sentences
Summary
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.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
Participants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included.
Summary · context
Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately.
Report a problemFND-4234847403
04HumanNon-randomized trialEfficacy outcome
In pubertal children with GH deficiency, height velocity remained stable for up to 130 weeks across treatment groups, including somapacitan.
In plain wordsIn pubertal children with GH deficiency, growth velocity remained stable across treatment groups, including somapacitan, for up to 130 weeks.
Peptide
Somapacitan
Outcome
No significant changePubertal height velocity stability
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
HV remained stable for up to 130 weeks in pubertal children, and was similar across treatment groups and Tanner stages.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
Participants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included.
Summary · context
Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately.
Report a problemFND-4234847404
05HumanNon-randomized trialEfficacy outcome
In pubertal children with GH deficiency, height velocity was similar across somapacitan and daily GH treatment groups.
In plain wordsIn pubertal children with GH deficiency, height velocity was similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
No significant changePubertal height velocity between treatments
Study
n: not reported in source
Comparator
Daily GH 0.034 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
HV remained stable for up to 130 weeks in pubertal children, and was similar across treatment groups and Tanner stages.
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
Participants receiving somapacitan 0.16 mg/kg/week or daily GH 0.034 mg/kg/day were included.
Summary · context
Some participants switched from daily GH to somapacitan after 52 weeks of treatment, so data beyond week 52 were analysed separately.
Report a problemFND-4234847405

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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Keywords

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