Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.

Juul A, Backeljauw P, Højby M, Frystyk J, Kawai M, Kildemoes RJ, Lemminger AK, Linglart A, Zuckerman-Levin N, Horikawa R

The Journal of clinical endocrinology and metabolism1 Mar 2025Cited by 8 (Europe PMC)

PMID39271158PMCIDPMC11913088DOI10.1210/clinem/dgae616PepBankPUB-39271158

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Summary

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

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children born SGA, somapacitan produced dose-dependent increases in total IGF-I, as did daily GH.
In plain wordsIn children born SGA, total IGF-I increased with somapacitan dose, as with daily GH.
Peptide
Somapacitan
Outcome
IncreaseDose-dependent total IGF-I increase
Study
n = 62
Comparator
Lower somapacitan doses
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16, 0.20, or 0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent increases in total IGF-I, as well as peak IGF-I bioactivity, were observed for both treatments and were similar between comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
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02HumanRandomized controlled trialEfficacy outcome
In children born SGA, peak IGF-I bioactivity increased with somapacitan dose, as it did with daily GH.
In plain wordsIn children born SGA, peak IGF-I activity increased with somapacitan dose, as with daily GH.
Peptide
Somapacitan
Outcome
IncreaseDose-dependent peak IGF-I bioactivity increase
Study
n = 62
Comparator
Lower somapacitan doses
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16, 0.20, or 0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent increases in total IGF-I, as well as peak IGF-I bioactivity, were observed for both treatments and were similar between comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
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03HumanRandomized controlled trialEfficacy outcome
In children born SGA, dose-dependent increases in total IGF-I with somapacitan and daily GH were reported as similar between comparator groups.
In plain wordsIn children born SGA, total IGF-I increases were reported as similar between the somapacitan and daily GH groups.
Peptide
Somapacitan
Outcome
Direction not reportedTotal IGF-I response
Study
n = 62
Comparator
Daily GH (0.035 or 0.067 mg/kg/day)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16, 0.20, or 0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent increases in total IGF-I, as well as peak IGF-I bioactivity, were observed for both treatments and were similar between comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115809
04HumanRandomized controlled trialEfficacy outcome
In children born SGA, dose-dependent increases in peak IGF-I bioactivity with somapacitan and daily GH were reported as similar between comparator groups.
In plain wordsIn children born SGA, peak IGF-I activity increases were reported as similar between the somapacitan and daily GH groups.
Peptide
Somapacitan
Outcome
Direction not reportedPeak IGF-I bioactivity response
Study
n = 62
Comparator
Daily GH (0.035 or 0.067 mg/kg/day)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16, 0.20, or 0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent increases in total IGF-I, as well as peak IGF-I bioactivity, were observed for both treatments and were similar between comparator groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
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05HumanRandomized controlled trialSafety outcome
In children born SGA, safety and tolerability were reported as similar across all groups, including the somapacitan and daily GH groups.
In plain wordsIn children born SGA, safety and tolerability were reported as similar across the somapacitan and daily GH groups.
Peptide
Somapacitan
Outcome
Direction not reportedSafety and tolerability
Study
n = 62
Comparator
Daily GH (0.035 or 0.067 mg/kg/day)
Outcome group
Adverse events · Whole body
Studied dose
0.16, 0.20, or 0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Similar safety and tolerability were demonstrated across all groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115813
06HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 8.5 cm/year with somapacitan 0.16 mg/kg/week versus 9.3 with daily GH 0.035 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically lower with somapacitan 0.16 mg/kg/week than daily GH 0.035 mg/kg/day.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.035 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
8.5 cm/year
somapacitan 0.16 mg/kg/week
Height velocity
9.3 cm/year
daily GH 0.035 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115801
07HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 8.5 cm/year with somapacitan 0.16 mg/kg/week versus 11.2 with daily GH 0.067 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically lower with somapacitan 0.16 mg/kg/week than daily GH 0.067 mg/kg/day.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.067 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
8.5 cm/year
somapacitan 0.16 mg/kg/week
Height velocity
11.2 cm/year
daily GH 0.067 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115802
08HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 10.4 cm/year with somapacitan 0.20 mg/kg/week versus 9.3 with daily GH 0.035 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically higher with somapacitan 0.20 mg/kg/week than daily GH 0.035 mg/kg/day.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.035 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.20 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.4 cm/year
somapacitan 0.20 mg/kg/week
Height velocity
9.3 cm/year
daily GH 0.035 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115803
09HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 10.4 cm/year with somapacitan 0.20 mg/kg/week versus 11.2 with daily GH 0.067 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically lower with somapacitan 0.20 mg/kg/week than daily GH 0.067 mg/kg/day.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.067 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.20 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.4 cm/year
somapacitan 0.20 mg/kg/week
Height velocity
11.2 cm/year
daily GH 0.067 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115804
10HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 10.7 cm/year with somapacitan 0.24 mg/kg/week versus 9.3 with daily GH 0.035 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically higher with somapacitan 0.24 mg/kg/week than daily GH 0.035 mg/kg/day.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.035 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.7 cm/year
somapacitan 0.24 mg/kg/week
Height velocity
9.3 cm/year
daily GH 0.035 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115805
11HumanRandomized controlled trialEfficacy outcome
In children born SGA, height velocity was 10.7 cm/year with somapacitan 0.24 mg/kg/week versus 11.2 with daily GH 0.067 mg/kg/day.
In plain wordsIn children born SGA, growth velocity was numerically lower with somapacitan 0.24 mg/kg/week than daily GH 0.067 mg/kg/day.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.067 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.7 cm/year
somapacitan 0.24 mg/kg/week
Height velocity
11.2 cm/year
daily GH 0.067 mg/kg/day
Source sentences
Summary
Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4, and 10.7 cm/year for somapacitan 0.16, 0.20, and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 62 GH-treatment-naïve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously.
Report a problemFND-3927115806

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

Subjects

Terms as the source lists them.

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Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.

Summary

Results from this study11

Version history

Subjects

Publication types

MeSH terms

Keywords