Skip to content

Study · Randomized controlled trial · 2026

6 results

Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial.

Linglart A, Böttcher V, Højby M, Soltysik K, Longui CA, Silverman L, Kashimada K

European journal of endocrinology1 Mar 2026

PMID41782416 (opens in a new tab)DOI10.1093/ejendo/lvag021 (opens in a new tab)PepBankPUB-41782416
Publisher pagePubMedAsk about this study
Jump to 6 results

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children born SGA, somapacitan height velocity was 11.0 versus 9.4 cm/year with daily GH 0.035 mg/kg/day, confirming noninferiority and superiority.

    In plain wordsIn children born SGA, somapacitan produced faster growth than daily GH 0.035 mg/kg/day.

    Peptide
    Somapacitan
    Outcome
    IncreaseHeight velocity at week 52
    Study

    n: not reported in source

    Comparator
    Daily GH 0.035 mg/kg/day
    Analysis
    Primary
    Outcome group
    Linear growth · Endocrine and hormones
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Height velocity
    11 cm/year
    somapacitan
    Height velocity
    9.4 cm/year
    daily GH 0.035 mg/kg/day
    ETD
    1.6 cm/year
    comparison
    95% CI
    0.91 to 2.23 cm/year
    ETD

    Source sentences

    Summary
    The primary endpoint, estimated mean height velocity at week 52, was 11.0 cm/year for somapacitan vs. 9.4 cm/year [ETD = 1.6(0.91, 2.23)95%CI] and 11.1 cm/year [ETD = -0.1(-0.75, 0.60)95%CI] for daily GH 0.035 and 0.067 mg/kg/day, respectively.
    3 context sentences
    Summary · context
    Noninferiority was confirmed for somapacitan compared to both daily GH groups. Superiority was demonstrated for somapacitan versus daily GH 0.035 mg/kg/day.
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children born SGA, somapacitan height velocity was 11.0 versus 11.1 cm/year with daily GH 0.067 mg/kg/day, confirming noninferiority.

    In plain wordsIn children born SGA, somapacitan growth velocity was numerically lower than daily GH 0.067 mg/kg/day, but met noninferiority criteria.

    Peptide
    Somapacitan
    Outcome
    DecreaseHeight velocity at week 52
    Study

    n: not reported in source

    Comparator
    Daily GH 0.067 mg/kg/day
    Analysis
    Primary
    Outcome group
    Linear growth · Endocrine and hormones
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Height velocity
    11 cm/year
    somapacitan
    Height velocity
    11.1 cm/year
    daily GH 0.067 mg/kg/day
    ETD
    −0.1 cm/year
    comparison
    95% CI
    −0.75 to 0.6 cm/year
    ETD

    Source sentences

    Summary
    The primary endpoint, estimated mean height velocity at week 52, was 11.0 cm/year for somapacitan vs. 9.4 cm/year [ETD = 1.6(0.91, 2.23)95%CI] and 11.1 cm/year [ETD = -0.1(-0.75, 0.60)95%CI] for daily GH 0.035 and 0.067 mg/kg/day, respectively.
    3 context sentences
    Summary · context
    Noninferiority was confirmed for somapacitan compared to both daily GH groups.
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.
  3. 03HumanRandomized controlled trialSafety outcome

    In children born SGA, somapacitan had a safety profile similar to daily GH 0.035 mg/kg/day.

    In plain wordsIn children born SGA, safety was similar with somapacitan and daily GH 0.035 mg/kg/day.

    Peptide
    Somapacitan
    Outcome
    No significant changeSafety profile
    Study

    n: not reported in source

    Comparator
    Daily GH 0.035 mg/kg/day
    Outcome group
    Adverse events · Whole body
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Safety profiles were similar between treatment groups.
    2 context sentences
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.
  4. 04HumanRandomized controlled trialSafety outcome

    In children born SGA, somapacitan had a safety profile similar to daily GH 0.067 mg/kg/day.

    In plain wordsIn children born SGA, safety was similar with somapacitan and daily GH 0.067 mg/kg/day.

    Peptide
    Somapacitan
    Outcome
    No significant changeSafety profile
    Study

    n: not reported in source

    Comparator
    Daily GH 0.067 mg/kg/day
    Outcome group
    Adverse events · Whole body
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Safety profiles were similar between treatment groups.
    2 context sentences
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.
  5. 05HumanNon-randomized trialOther

    In children born SGA, disease burden decreased with somapacitan at week 52, as it did with daily GH 0.067 mg/kg/day.

    In plain wordsIn children born SGA, disease burden decreased with somapacitan, as with daily GH 0.067 mg/kg/day.

    Peptide
    Somapacitan
    Outcome
    DecreaseDisease burden at week 52
    Study

    n: not reported in source

    Outcome group
    Disease burden · Whole body
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, somapacitan reduced disease burden at week 52, as for daily GH 0.067 mg/kg/day, while somapacitan was associated with reduced treatment burden.
    2 context sentences
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.
  6. 06HumanNon-randomized trialOther

    In children born SGA, somapacitan was associated with reduced treatment burden; the result did not specify the comparator.

    In plain wordsIn children born SGA, somapacitan was linked to lower treatment burden. The result did not specify the comparator.

    Peptide
    Somapacitan
    Outcome
    DecreaseTreatment burden
    Study

    n: not reported in source

    Outcome group
    Patterns of use · Whole body
    Studied dose
    .24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    As expected, somapacitan reduced disease burden at week 52, as for daily GH 0.067 mg/kg/day, while somapacitan was associated with reduced treatment burden.
    2 context sentences
    Summary · context
    142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously.
    Summary · context
    140 completed the main 52-week treatment period.

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.

  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.

PepBank is a research reference. Talk to a doctor before you use any peptide.