Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4.

Miller BS, Blair JC, Rasmussen MH, Frystyk J, Lemminger AK, Maniatis A, Mori J, Böttcher V, Kim HS, Polak M, Horikawa R

European journal of endocrinology1 Apr 2025Cited by 7 (Europe PMC)

PMID40400262DOI10.1093/ejendo/lvaf096PepBankPUB-40400262

Publisher page PubMedAsk about this study

Summary

ObjectiveSomapacitan is a long-acting GH approved for once-weekly treatment of GH deficiency (GHD). This study aims to evaluate the efficacy and tolerability of somapacitan after 3 years of treatment and 2 years after switch from daily GH in children with GHD.DesignRandomized, multi-national, open-labelled, active-controlled parallel-group phase 3 trial, with a 52-week main phase and 3-year safety extension (NCT03811535).MethodsTreatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).ResultsOf 200 participants, 188 completed 3 years of treatment. Sustained growth was observed in both groups. At week 156, mean (SD) height velocity (HV) between weeks 104 and 156 was 7.4 (1.5) cm/year in the soma/soma group and 7.8 (1.4) cm/year in the switch group. At week 156, the soma/soma and switch groups had reached a mean (SD) height SD score (HSDS) of -0.95 (0.98) and -1.08 (0.93), respectively, and were approaching the mean mid-parental HSDS of -0.74 (for both groups). Mean total insulin-like growth factor I (IGF-I) SDS during year 3 was similar between groups and within normal range (-2.0 to +2.0). Bioactive IGF-I and bioactive IGF-I to IGF-I ratio were similar between groups. Somapacitan was well tolerated, with low proportions reporting injection-site reactions.ConclusionsSustained efficacy and tolerability were observed for continuous somapacitan treatment for 3 years, and for 2 years after the switching from daily GH treatment. HSDS in both groups was approaching mean mid-parental HSDS.Clinical trial registrationNCT03811535.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with GHD, total IGF-I SDS during year 3 was similar between continuous and switched somapacitan groups and within normal range.
In plain wordsIn children with GHD, total IGF-I SDS was similar between continuous and switched somapacitan groups during year 3.
Peptide
Somapacitan
Outcome
Direction not reportedTotal IGF-I SDS
Study
n = 200
Comparator
Somapacitan after daily GH
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Normal range
−2 to 2 SDS
Source sentences
Summary
Mean total insulin-like growth factor I (IGF-I) SDS during year 3 was similar between groups and within normal range (-2.0 to +2.0).
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026205
02HumanRandomized controlled trialEfficacy outcome
In children with GHD, bioactive IGF-I was similar between continuous and switched somapacitan groups.
In plain wordsIn children with GHD, bioactive IGF-I was similar between continuous and switched somapacitan groups.
Peptide
Somapacitan
Outcome
Direction not reportedBioactive IGF-I
Study
n = 200
Comparator
Somapacitan after daily GH
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Bioactive IGF-I and bioactive IGF-I to IGF-I ratio were similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026206
03HumanRandomized controlled trialEfficacy outcome
In children with GHD, bioactive IGF-I to IGF-I ratio was similar between the soma/soma group and the daily GH-then-somapacitan switch group.
In plain wordsIn children with GHD, the bioactive IGF-I ratio was similar between the continuous somapacitan group and the group switched from daily GH.
Peptide
Somapacitan
Outcome
No significant changeBioactive IGF-I to IGF-I ratio
Study
n: not reported in source
Comparator
Switch group (daily GH followed by somapacitan)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Bioactive IGF-I and bioactive IGF-I to IGF-I ratio were similar between groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026207
04HumanNon-randomized trialEfficacy outcome
In children with GHD receiving continuous somapacitan, mean height velocity between weeks 104 and 156 was 7.4 cm/year.
In plain wordsIn children with GHD receiving continuous somapacitan, mean growth speed between weeks 104 and 156 was 7.4 cm/year.
Peptide
Somapacitan
Outcome
Not applicableHeight velocity, continuous treatment
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 3 yearsAs given in this study (human).
Measurements
Height velocity
7.4 cm/year
continuous somapacitan
SD
1.5 cm/year
Source sentences
Summary
At week 156, mean (SD) height velocity (HV) between weeks 104 and 156 was 7.4 (1.5) cm/year in the soma/soma group and 7.8 (1.4) cm/year in the switch group.
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026201
05HumanNon-randomized trialEfficacy outcome
In children with GHD switched to somapacitan, mean height velocity between weeks 104 and 156 was 7.8 cm/year.
In plain wordsIn children with GHD switched to somapacitan, mean growth speed between weeks 104 and 156 was 7.8 cm/year.
Peptide
Somapacitan
Outcome
Not applicableHeight velocity, switch group
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 2 yearsAs given in this study (human).
Measurements
Height velocity
7.8 cm/year
switch group
SD
1.4 cm/year
Source sentences
Summary
At week 156, mean (SD) height velocity (HV) between weeks 104 and 156 was 7.4 (1.5) cm/year in the soma/soma group and 7.8 (1.4) cm/year in the switch group.
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026202
06HumanNon-randomized trialEfficacy outcome
In children with GHD receiving continuous somapacitan, mean height SDS reached -0.95 at week 156.
In plain wordsIn children with GHD receiving continuous somapacitan, mean height SDS reached -0.95 at week 156.
Peptide
Somapacitan
Outcome
Not applicableHeight SDS, continuous treatment
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 3 yearsAs given in this study (human).
Measurements
Height SDS
−0.95
continuous somapacitan
SD
0.98
Mid-parental HSDS
−0.74
Source sentences
Summary
At week 156, the soma/soma and switch groups had reached a mean (SD) height SD score (HSDS) of -0.95 (0.98) and -1.08 (0.93), respectively, and were approaching the mean mid-parental HSDS of -0.74 (for both groups).
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026203
07HumanNon-randomized trialEfficacy outcome
In children with GHD switched to somapacitan, mean height SDS reached -1.08 at week 156.
In plain wordsIn children with GHD switched to somapacitan, mean height SDS reached -1.08 at week 156.
Peptide
Somapacitan
Outcome
Not applicableHeight SDS, switch group
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 2 yearsAs given in this study (human).
Measurements
Height SDS
−1.08
switch group
SD
0.93
Mid-parental HSDS
−0.74
Source sentences
Summary
At week 156, the soma/soma and switch groups had reached a mean (SD) height SD score (HSDS) of -0.95 (0.98) and -1.08 (0.93), respectively, and were approaching the mean mid-parental HSDS of -0.74 (for both groups).
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026204
08HumanNon-randomized trialSafety outcome
In children with GHD, somapacitan was well tolerated with low proportions reporting injection-site reactions.
In plain wordsIn children with GHD, somapacitan was well tolerated, with a low proportion reporting injection-site reactions.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Somapacitan was well tolerated, with low proportions reporting injection-site reactions.
1 context sentence(design, population, supporting numbers)
Summary · context
Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; "soma/soma" group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; "switch" group).
Show in the study text Report a problemFND-4040026208

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03811535

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Novo Nordisk A/Sn = 20020 May 2019 to 30 Sept 2025

Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 22 Oct 2026

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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