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Study · Non-randomized trial · n = 50 · 2023

4 results

Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.

Sävendahl L, Battelino T, Højby Rasmussen M, Brod M, Röhrich S, Saenger P, Horikawa R

The Journal of clinical endocrinology and metabolism1 Sept 2023Cited by 32 (Europe PMC)

PMID36995872 (opens in a new tab)PMCIDPMC10505532 (opens in a new tab)DOI10.1210/clinem/dgad183 (opens in a new tab)PepBankPUB-36995872
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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-ND. 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 with GHD, height velocity changes were similar with continued somapacitan and after switching from daily GH.

    In plain wordsIn children with GHD, growth speed changes were similar with continued somapacitan and after switching from daily GH.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedHeight velocity change
    Study

    n = 50

    Comparator
    Switched from daily GH to somapacitan
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.04, 0.08 or 0.16 mg/kg/week for 1 year, then 0.16 mg/kg/week for 3 years · 4 yearsAs given in this study (human).

    Source sentences

    Summary
    Changes from baseline in HV and HV SDS were similar and as expected in both groups.
    3 context sentences
    Summary · context
    Patients were prepubertal, GH-naive children with GHD.
    Summary · context
    Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week) for 1 year, followed by the highest dose (0.16 mg/kg/week) for 3 years.
    Summary · context
    Patients in the switched group received daily GH 0.034 mg/kg/day for 3 years, then somapacitan 0.16 mg/kg/week for 1 year.
  2. 02HumanNon-randomized trialEfficacy outcome

    In children with GHD, height velocity SDS changes were similar with continued somapacitan and after switching from daily GH.

    In plain wordsIn children with GHD, growth speed score changes were similar with continued somapacitan and after switching from daily GH.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedHeight velocity SDS change
    Study

    n = 50

    Comparator
    Switched from daily GH to somapacitan
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.04, 0.08 or 0.16 mg/kg/week for 1 year, then 0.16 mg/kg/week for 3 years · 4 yearsAs given in this study (human).

    Source sentences

    Summary
    Changes from baseline in HV and HV SDS were similar and as expected in both groups.
    3 context sentences
    Summary · context
    Patients were prepubertal, GH-naive children with GHD.
    Summary · context
    Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week) for 1 year, followed by the highest dose (0.16 mg/kg/week) for 3 years.
    Summary · context
    Patients in the switched group received daily GH 0.034 mg/kg/day for 3 years, then somapacitan 0.16 mg/kg/week for 1 year.
  3. 03HumanNon-randomized trialEfficacy outcome

    In children with GHD and their parents, observer reports suggested reduced treatment burden after switching from daily GH to somapacitan.

    In plain wordsChildren with GHD and their parents seemed to experience less treatment burden after switching from daily GH to somapacitan.

    Peptide
    Somapacitan
    Outcome
    DecreaseTreatment burden after switching
    Study

    n: not reported in source

    Comparator
    Prior daily GH
    Outcome group
    Device usability · Endocrine and hormones
    Studied dose
    0.16 mg/kg/week · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Observer-reported outcomes showed that patients and parents/guardians seem to have experienced a reduced treatment burden when switching from daily GH to somapacitan.
    3 context sentences
    Summary · context
    Patients were prepubertal, GH-naive children with GHD.
    Summary · context
    Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week) for 1 year, followed by the highest dose (0.16 mg/kg/week) for 3 years.
    Summary · context
    Patients in the switched group received daily GH 0.034 mg/kg/day for 3 years, then somapacitan 0.16 mg/kg/week for 1 year.
  4. 04HumanNon-randomized trialEfficacy outcome

    Among parents of children with GHD, 81.8% strongly or very strongly preferred somapacitan over daily GH.

    In plain wordsAmong parents of children with GHD, 81.8% strongly or very strongly preferred somapacitan over daily GH.

    Peptide
    Somapacitan
    Outcome
    Not applicableParent treatment preference
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Treatment Preference · Endocrine and hormones
    Studied dose
    Dose not stated

    Measurements

    Strong or very strong preference
    81.8%
    Parents/guardians

    Source sentences

    Summary
    Most parents/guardians (81.8%) strongly/very strongly preferred somapacitan over daily GH.
    3 context sentences
    Summary · context
    Patients were prepubertal, GH-naive children with GHD.
    Summary · context
    Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week) for 1 year, followed by the highest dose (0.16 mg/kg/week) for 3 years.
    Summary · context
    Patients in the switched group received daily GH 0.034 mg/kg/day for 3 years, then somapacitan 0.16 mg/kg/week for 1 year.

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

CompletedPhase 2Results postedNCT02616562

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Novo Nordisk A/Sn = 7631 Mar 2016 to 26 Sept 2024

Growth Hormone Disorder · Growth Hormone Deficiency in Children

Trial pageClinicalTrials.govUpdated 16 Jan 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.

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