Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial.

Mori J, Ohata Y, Fujisawa Y, Sato Y, Röhrich S, Rasmussen MH, Bang RB, Horikawa R

Clinical endocrinology18 Feb 2024Cited by 16 (Europe PMC)

PMID38368603DOI10.1111/cen.15025PepBankPUB-38368603

Publisher page PubMedAsk about this study

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-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese children with GHD, mean height velocity at week 52 was 10.3 with somapacitan versus 9.8 cm/year with daily GH, described as similar.
In plain wordsIn Japanese children with GHD, growth speed was similar with somapacitan and daily GH at week 52.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity at week 52
Study
n = 30
Comparator
Daily GH
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.3 cm/year
somapacitan
Height velocity
9.8 cm/year
daily GH
Source sentences
Summary
At Week 52, observed mean HV was similar between treatment groups (10.3 vs. 9.8 cm/year for somapacitan and daily GH, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860301
02HumanRandomized controlled trialEfficacy outcome
In Japanese children with GHD, week 104 height velocity was 7.4 with continuous somapacitan versus 7.9 cm/year after switching, described as similar.
In plain wordsIn Japanese children with GHD, growth speed was similar between continuous and switched somapacitan groups at week 104.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 104
Study
n: not reported in source
Comparator
Somapacitan after daily GH
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Height velocity
7.4 cm/year
continuous somapacitan
Height velocity
7.9 cm/year
switch group
Source sentences
Summary
Similar HVs between groups were also observed at Week 104: 7.4 cm/year after continuous somapacitan treatment (soma/soma) and 7.9 cm/year after 1-year somapacitan treatment following switch from daily GH (switch).
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860302
03HumanNon-randomized trialEfficacy outcome
In Japanese children with GHD, other height-related endpoints supported continuous growth during somapacitan treatment.
In plain wordsIn Japanese children with GHD, other height measures supported continued growth during somapacitan treatment.
Peptide
Somapacitan
Outcome
Direction not reportedOther height-related endpoints
Study
n: not reported in source
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
Other height-related endpoints supported continuous growth.
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860303
04HumanNon-randomized trialEfficacy outcome
In Japanese children with GHD, IGF-I SDS increased in both treatment groups, with means within -2 and +2 during the study.
In plain wordsIn Japanese children with GHD, IGF-I SDS increased in both treatment groups, with mean values between -2 and +2 during the study.
Peptide
Somapacitan
Outcome
IncreaseIGF-I SDS
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Mean IGF-I SDS range
−2 to 2
during study
Source sentences
Summary
IGF-I SDS increased in both groups with mean IGF-I SDS within -2 and +2 during the study.
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860304
05HumanNon-randomized trialSafety outcome
In Japanese children with GHD receiving somapacitan, one mild injection-site reaction was reported.
In plain wordsIn Japanese children with GHD receiving somapacitan, one mild injection-site reaction occurred.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reaction
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).
Measurements
Injection-site reactions
1 event
mild
Source sentences
Summary
Somapacitan was well tolerated, one mild injection site reaction was reported, with no reports of injection site pain.
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860305
06HumanNon-randomized trialSafety outcome
In Japanese children with GHD receiving somapacitan, no injection-site pain was reported.
In plain wordsIn Japanese children with GHD receiving somapacitan, no injection-site pain was reported.
Peptide
Somapacitan
Outcome
Not applicableInjection-site pain
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, one mild injection site reaction was reported, with no reports of injection site pain.
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860306
07HumanNon-randomized trialEfficacy outcome
Among Japanese patients with GHD and caregivers who switched treatment, 90.9% preferred weekly somapacitan over daily GH.
In plain wordsAmong Japanese patients with GHD and caregivers who switched treatment, 90.9% preferred weekly somapacitan over daily GH.
Peptide
Somapacitan
Outcome
IncreaseTreatment preference
Study
n: not reported in source
Comparator
Daily GH
Outcome group
Patient-reported outcomes · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Preference
90.9%
weekly somapacitan over daily GH
Source sentences
Summary
Patient preference questionnaires showed that most patients and their caregivers (90.9%) who switched treatment at Week 52 preferred once-weekly somapacitan over daily GH treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535).
Summary · context
Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan.
Report a problemFND-3836860307

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 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
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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