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Study · Non-randomized trial · 2026

4 results

Somapacitan in children born small for gestational age: 4-year results from phase 2.

Juul A, Højby M, Kawai M, Linglart A, Mori J, Zuckerman-Levin N, Backeljauw P

European journal of endocrinology1 Feb 2026Cited by 1 (Europe PMC)

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. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In children born SGA, height standard deviation scores increased continuously across all treatment arms from week 52 to week 208, including after switch to somapacitan 0.24 mg/kg/week.

    In plain wordsIn children born SGA, height scores increased across all treatment arms, including after switching to somapacitan.

    Outcome
    IncreaseHeight standard deviation score
    Study

    n: not reported in source

    Outcome group
    Linear growth · Endocrine and hormones
    Studied dose
    somapacitan 0.24 mg/kg/week after switch · week 52 to week 208As given in this study (human).

    Source sentences

    Summary
    Across all treatment arms, continuous increases in height standard deviation scores were observed from week 52 to week 208, including after switch to somapacitan 0.24 mg/kg/week.
    2 context sentences
    Summary · context
    Forty-eight participants switched to somapacitan 0.24 mg/kg/week from cohorts randomized to daily GH or lower somapacitan doses.
    Summary · context
    Novel safety and efficacy results from week 52 to 208 are presented here.
  2. 02HumanNon-randomized trialSafety outcome

    In children born SGA, somapacitan had a safety and tolerability profile similar to the established daily GH profile.

    In plain wordsIn children born SGA, somapacitan safety and tolerability resembled the established daily GH profile.

    Outcome
    No significant changeSafety and tolerability profile
    Study

    n: not reported in source

    Comparator
    Established daily GH safety and tolerability profile in SGA
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.24 mg/kg/week · week 52 to week 208As given in this study (human).

    Source sentences

    Summary
    The safety and tolerability profile for somapacitan 0.24 mg/kg/week was similar to the well-established safety and tolerability profile for daily GH in SGA.
    2 context sentences
    Summary · context
    Forty-eight participants switched to somapacitan 0.24 mg/kg/week from cohorts randomized to daily GH or lower somapacitan doses.
    Summary · context
    Novel safety and efficacy results from week 52 to 208 are presented here.
  3. 03HumanNon-randomized trialOther

    Among respondents in the study of children born SGA, 87% preferred somapacitan over daily GH.

    In plain wordsAmong respondents, 87% preferred somapacitan over daily GH for children born SGA.

    Outcome
    Not applicableTreatment preference
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Patterns of use · Whole body
    Studied dose
    Dose not stated

    Measurements

    Preference
    87%
    somapacitan over daily GH

    Source sentences

    Summary
    Patient preference questionnaire results indicate that most respondents (87%) prefer somapacitan over daily GH.
    2 context sentences
    Summary · context
    Forty-eight participants switched to somapacitan 0.24 mg/kg/week from cohorts randomized to daily GH or lower somapacitan doses.
    Summary · context
    Novel safety and efficacy results from week 52 to 208 are presented here.
  4. 04HumanNon-randomized trialOther

    Among respondents in the study of children born SGA, 80% expected greater treatment adherence with somapacitan.

    In plain wordsAmong respondents, 80% expected greater treatment adherence with somapacitan for children born SGA.

    Outcome
    Not applicableExpected adherence
    Study

    n: not reported in source

    Outcome group
    Patterns of use · Whole body
    Studied dose
    Dose not stated

    Measurements

    Expected greater adherence
    80%
    respondents

    Source sentences

    Summary
    Most respondents (80%) answered that they expect to be more adherent to treatment with somapacitan.
    2 context sentences
    Summary · context
    Forty-eight participants switched to somapacitan 0.24 mg/kg/week from cohorts randomized to daily GH or lower somapacitan doses.
    Summary · context
    Novel safety and efficacy results from week 52 to 208 are presented here.

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

Active, not recruitingPhase 2Results postedNCT03878446

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Novo Nordisk A/Sn = 624 Jul 2019 to est. 23 Dec 2026

Short Stature Children Born Small for Gestational Age (SGA)

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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