Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study.

Abuzzahab J, Dauber A, Højby M, Soltysik K, Kawai M, Murray PG, Phillip M, Battelino T

European journal of endocrinology1 Feb 2026

PMID41712606DOI10.1093/ejendo/lvag027PepBankPUB-41712606

Publisher page PubMedAsk about this study

Summary

ObjectiveDaily growth hormone (GH) injections restore normal growth and improve psychological outcomes in children with idiopathic short stature (ISS) but treatment burden is significant. The objective of this study is to demonstrate efficacy and safety of once-weekly somapacitan, a long-acting GH, in children with ISS.DesignREAL8 (ClinicalTrials.gov: NCT05330325) is a global, randomized, open-labelled, active-comparator, phase 3 basket study including 4 non-GH deficiency indications comprising a 52-week main phase and 104-week extension. Here, we present 52-week results from the REAL8 ISS study.MethodsEighty-eight pre-pubertal, treatment-naive children with ISS at clinics in 20 countries were randomized 2:1 to somapacitan .24 mg/kg/week or daily GH 0.050 mg/kg/day, both administered subcutaneously. Eighty-five children completed the main 52-week treatment period.ResultsObserved mean height velocity, HV, (SD) at week 52 was 10.2 (1.7) and 10.6 (1.6) cm/year for somapacitan and daily GH groups, respectively (estimated treatment difference [ETD]: -0.3 cm/year [-1.00;0.42]95%CI, non-inferiority confirmed). Safety profiles were similar (somapacitan: 191 events in 47 (79.7%) participants, daily GH: 87 events in 22 (78.6%) participants) with most adverse events (AEs) mild and unlikely related to study product. Disease and treatment burden questionnaires presented favourable results.ConclusionsSimilar efficacy and safety were confirmed for once-weekly somapacitan versus daily GH in treatment-naïve children with ISS, with favourable patient-reported outcome measures, setting the ground for future treatment for ISS with a once-weekly option.Clinical study registrationNCT05330325.

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

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with ISS, somapacitan height velocity was 10.2 versus 10.6 cm/year with daily GH, confirming non-inferiority.
In plain wordsIn children with ISS, growth velocity was numerically lower with somapacitan than daily GH, but met non-inferiority criteria.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n: not reported in source
Comparator
Daily GH 0.050 mg/kg/day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
10.2 cm/year
somapacitan
SD
1.7 cm/year
somapacitan
Height velocity
10.6 cm/year
daily GH
SD
1.6 cm/year
daily GH
ETD
−0.3 cm/year
somapacitan versus daily GH
95% CI
−1 to 0.42 cm/year
ETD
Source sentences
Summary
Observed mean height velocity, HV, (SD) at week 52 was 10.2 (1.7) and 10.6 (1.6) cm/year for somapacitan and daily GH groups, respectively (estimated treatment difference [ETD]: -0.3 cm/year [-1.00;0.42]95%CI, non-inferiority confirmed).
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty-eight pre-pubertal, treatment-naive children with ISS at clinics in 20 countries were randomized 2:1 to somapacitan .24 mg/kg/week or daily GH 0.050 mg/kg/day, both administered subcutaneously.
Show in the study text Report a problemFND-4171260601
02HumanRandomized controlled trialSafety outcome
In children with ISS, safety profiles were similar with somapacitan and daily GH, with most adverse events mild and unlikely treatment-related.
In plain wordsIn children with ISS, safety profiles were similar with somapacitan and daily GH. Most adverse events were mild.
Peptide
Somapacitan
Outcome
No significant changeAdverse events
Study
n: not reported in source
Comparator
Daily GH 0.050 mg/kg/day
Outcome group
Adverse events · Whole body
Studied dose
.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Events
191 events
somapacitan
Affected participants
47 participants
somapacitan
Affected participants
79.7%
somapacitan
Events
87 events
daily GH
Affected participants
22 participants
daily GH
Affected participants
78.6%
daily GH
Source sentences
Summary
Safety profiles were similar (somapacitan: 191 events in 47 (79.7%) participants, daily GH: 87 events in 22 (78.6%) participants) with most adverse events (AEs) mild and unlikely related to study product.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty-eight pre-pubertal, treatment-naive children with ISS at clinics in 20 countries were randomized 2:1 to somapacitan .24 mg/kg/week or daily GH 0.050 mg/kg/day, both administered subcutaneously.
Show in the study text Report a problemFND-4171260602

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 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 3NCT05330325

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Novo Nordisk A/Sn = 41210 Aug 2022 to est. 29 Oct 2027

SGA, Turner Syndrome, Noonan Syndrome, ISS

Trial page ClinicalTrials.govUpdated 12 Jun 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.

Publication types

Journal Article

Keywords

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