Skip to content

Study · Randomized controlled trial · n = 77 · 2026

3 results

Once-weekly somapacitan in children with Noonan syndrome: randomized controlled phase 3 trial.

Jorge AAL, Albanese A, Højby M, Soltysik K, Edouard T, Grandone A, Tansey M, Mori J

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

PMID41774755 (opens in a new tab)DOI10.1093/ejendo/lvag041 (opens in a new tab)PepBankPUB-41774755
Publisher pagePubMedAsk about this study
Jump to 3 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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with Noonan syndrome, somapacitan increased annualized height velocity versus daily GH, confirming noninferiority and superiority (P < .01).

    In plain wordsIn children with Noonan syndrome, somapacitan produced faster growth than daily GH.

    Peptide
    Somapacitan
    Outcome
    IncreaseAnnualized height velocity at week 52
    Study

    n = 77

    Comparator
    Daily GH 0.050 mg/kg/day
    Analysis
    Primary
    Outcome group
    Linear growth · Endocrine and hormones
    Studied dose
    0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Height velocity
    10.4 cm/year
    somapacitan
    Height velocity
    9.2 cm/year
    daily GH
    ETD
    1.2 cm/year
    somapacitan versus daily GH
    95% CI
    0.32 to 2.03 cm/year
    ETD
    P
    < 0.01
    superiority

    Source sentences

    Summary
    The primary endpoint, estimated mean annualized height velocity at week 52, was 10.4 cm/year for somapacitan versus 9.2 cm/year for daily GH (estimated treatment difference [ETD]: 1.2, 95% CI [0.32; 2.03]), confirming noninferiority and demonstrating superiority of somapacitan compared to daily GH (P < .01).
    1 context sentence
    Summary · context
    Seventy-seven GH-treatment-naïve, prepubertal boys (aged 2.5-11 years) and girls (aged 2.5-10 years) with Noonan syndrome were randomized 2:1 to somapacitan 0.24 mg/kg/week or daily GH 0.050 mg/kg/day, administered subcutaneously.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with Noonan syndrome, height score increased by 1.07 with somapacitan versus 0.75 with daily GH at week 52.

    In plain wordsIn children with Noonan syndrome, height scores increased more with somapacitan than daily GH.

    Peptide
    Somapacitan
    Outcome
    IncreaseHeight standard deviation score change
    Study

    n = 77

    Comparator
    Daily GH 0.050 mg/kg/day
    Outcome group
    Linear growth · Endocrine and hormones
    Studied dose
    0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Height SDS change
    1.07
    somapacitan
    Height SDS change
    0.75
    daily GH
    ETD
    0.32
    height SDS
    95% CI
    0.16 to 0.48
    ETD

    Source sentences

    Summary
    The estimated change from baseline to week 52 in height standard deviation score was 1.07 and 0.75 for somapacitan and daily GH, respectively (ETD: 0.32, 95% CI [0.16; 0.48]).
    1 context sentence
    Summary · context
    Seventy-seven GH-treatment-naïve, prepubertal boys (aged 2.5-11 years) and girls (aged 2.5-10 years) with Noonan syndrome were randomized 2:1 to somapacitan 0.24 mg/kg/week or daily GH 0.050 mg/kg/day, administered subcutaneously.
  3. 03HumanRandomized controlled trialSafety outcome

    In children with Noonan syndrome, somapacitan was well tolerated and had a safety profile similar to daily GH.

    In plain wordsIn children with Noonan syndrome, somapacitan was well tolerated, with safety similar to daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeSafety and tolerability
    Study

    n = 77

    Comparator
    Daily GH 0.050 mg/kg/day
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Somapacitan was well tolerated and had a similar safety profile to daily GH.
    1 context sentence
    Summary · context
    Seventy-seven GH-treatment-naïve, prepubertal boys (aged 2.5-11 years) and girls (aged 2.5-10 years) with Noonan syndrome were randomized 2:1 to somapacitan 0.24 mg/kg/week or daily GH 0.050 mg/kg/day, administered subcutaneously.

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 pageClinicalTrials.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.

  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.