Seven-year Safety and Efficacy of Somapacitan in Children With GH Deficiency: Final Results From REAL 3.

Sävendahl L, Battelino T, Højby M, Leunbach T, Saenger P, Silverman L, Horikawa R

Journal of the Endocrine Society21 Nov 2025Cited by 4 (Europe PMC)

PMID41394116PMCIDPMC12699150DOI10.1210/jendso/bvaf189PepBankPUB-41394116

Summary

BackgroundSomapacitan is a once-weekly GH treatment that has shown efficacy and safety profiles equivalent to daily GH in children with GH deficiency (GHD).ObjectiveTo investigate long-term safety, efficacy, and treatment burden associated with somapacitan after 7 years (364 weeks) of treatment.MethodsREAL 3 (NCT02616562) was a phase 2, randomized, open-label trial investigating the efficacy and safety of somapacitan vs daily GH in children with GHD. After 156 weeks, participants entered a 208-week safety extension. Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment. All participants received somapacitan 0.16 mg/kg/week. Height velocity (HV), HV SD score (SDS), height SDS, IGF-I SDS, incidence of adverse events (AEs), and treatment burden were assessed.ResultsOverall, 43 participants (73%) in cohort I, 1 participant (100%) in cohort II, and 11 participants (69%) in cohort III completed the 208-week safety extension. Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0. The incidence of AEs was aligned with previous investigations across all cohorts; 3 serious AEs in cohort I were considered probably/possibly related to treatment. Treatment burden was reduced in children who switched from daily GH to somapacitan.ConclusionAfter 7 years of treatment, children with GHD receiving somapacitan experienced consistent increases in height SDS and reduced treatment burden. No new safety concerns were identified.

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

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialEfficacy outcome
In children with GHD in cohort I receiving somapacitan, height velocity showed consistent increments.
In plain wordsIn children with GHD in cohort I receiving somapacitan, height velocity increased consistently.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity in cohort I
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
Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411604
02HumanNon-randomized trialEfficacy outcome
In children with GHD in cohort I receiving somapacitan, height velocity SDS showed consistent increments.
In plain wordsIn children with GHD in cohort I receiving somapacitan, height velocity scores increased consistently.
Peptide
Somapacitan
Outcome
IncreaseHeight velocity SDS in cohort I
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
Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411605
03HumanNon-randomized trialEfficacy outcome
In children with GHD in cohort I receiving somapacitan, height SDSs were close to 0 at week 364.
In plain wordsIn children with GHD in cohort I receiving somapacitan, height scores were close to 0 at week 364.
Peptide
Somapacitan
Outcome
Not applicableHeight SDS at week 364 in cohort I
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
Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411606
04HumanNon-randomized trialSafety outcome
Across cohorts of children with GHD receiving somapacitan, adverse-event incidence aligned with previous investigations.
In plain wordsAcross cohorts of children with GHD receiving somapacitan, adverse-event incidence aligned with previous investigations.
Peptide
Somapacitan
Outcome
Not applicableAdverse-event incidence
Study
n: not reported in source
Comparator
Previous investigations
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
The incidence of AEs was aligned with previous investigations across all cohorts; 3 serious AEs in cohort I were considered probably/possibly related to treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411607
05HumanNon-randomized trialSafety outcome
In children with GHD in cohort I receiving somapacitan, 3 serious adverse events were considered probably or possibly treatment-related.
In plain wordsIn children with GHD in cohort I receiving somapacitan, 3 serious adverse events were considered probably or possibly treatment-related.
Peptide
Somapacitan
Outcome
Not applicableTreatment-related serious adverse events in cohort I
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Serious adverse events probably/possibly related to treatment
3 events
cohort I
Source sentences
Summary
The incidence of AEs was aligned with previous investigations across all cohorts; 3 serious AEs in cohort I were considered probably/possibly related to treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411608
06HumanNon-randomized trialEfficacy outcome
In children with GHD who switched from daily GH to somapacitan, treatment burden decreased.
In plain wordsIn children with GHD who switched from daily GH to somapacitan, treatment burden decreased.
Peptide
Somapacitan
Outcome
DecreaseTreatment burden after switching
Study
n: not reported in source
Comparator
Prior daily GH treatment
Outcome group
Patterns of use · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Treatment burden was reduced in children who switched from daily GH to somapacitan.
3 context sentences(design, population, supporting numbers)
Summary · context
After 156 weeks, participants entered a 208-week safety extension.
Summary · context
Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment.
Summary · context
All participants received somapacitan 0.16 mg/kg/week.
Show in the study text Report a problemFND-4139411609

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

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Keywords

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