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Study · Observational study · 2022

1 result

Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency.

Kildemoes RJ, Hollensen C, Biller BMK, Johannsson G, Takahashi Y, Rasmussen MH

European journal of endocrinology16 May 2022Cited by 11 (Europe PMC)

PMID35521713 (opens in a new tab)PMCIDPMC9175552 (opens in a new tab)DOI10.1530/eje-21-1167 (opens in a new tab)PepBankPUB-35521713
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Summary

ObjectiveGrowth hormone (GH) replacement therapy in patients with adult growth hormone deficiency (AGHD) is individually titrated due to variable dose-responses among patients. The aim of this study was to provide clinical guidance on dosing and titration of the novel long-acting GH derivative somapacitan based on analyses of somapacitan dose-insulin-like growth factor I (IGF-I) responses in AGHD patients.DesignAnalyses of dosing information, 4364 somapacitan concentration samples and 4880 IGF-I samples from 330 AGHD patients treated with somapacitan in three phase 3 trials.MethodsPharmacokinetic/pharmacodynamic modelling was used to evaluate starting dose groups by age and oral oestrogen therapy, characterise the dose-IGF-I response in the overall AGHD population and patient subgroups, predict the IGF-I response to dose changes and simulate missed dosing.ResultsThe analyses supported the clinical recommendations of higher starting doses for younger patients and women on oral oestrogen replacement therapy. For patients switching from daily GH treatment, the mean maintenance dose ratio between somapacitan (mg/week) and somatropin (mg/day) was predicted to be 8.2 (observed interquartile range of 6.7-9.1). Simulations of IGF-I SDS profiles confirmed the appropriate time for IGF-I sampling to be 3-4 days after somapacitan dosing and supported somapacitan administration with up to 3 days delay in case of missed dosing. Subgroup analyses characterised the dose-exposure-IGF-I response in patient subgroups and indicated that dose requirements are mainly influenced by sex and oral oestrogen treatment.ConclusionsThis study extends the knowledge of the somapacitan dose-IGF-I response and provides information on clinical dosing of once-weekly somapacitan in patients with AGHD.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanObservational studyPharmacokinetics

    In adults with GHD switching from daily GH, the model-predicted mean maintenance dose ratio of somapacitan (mg/week) to somatropin (mg/day) was 8.2, with an observed interquartile range of 6.7-9.1.

    In plain wordsFor adults switching from daily GH, the model-predicted weekly somapacitan to daily somatropin dose ratio averaged 8.2; the observed interquartile range was 6.7-9.1.

    Peptide
    Somapacitan
    Outcome
    Not applicableMaintenance dose ratio when switching from daily GH
    Study

    n: not reported in source

    Comparator
    Somatropin daily dose
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Maintenance dose ratio, model-predicted mean
    8.2 mg/week per mg/day
    Patients switching from daily GH
    Maintenance dose ratio interquartile range
    6.7 to 9.1 mg/week per mg/day
    Observed, patients switching from daily GH

    Source sentences

    Summary
    For patients switching from daily GH treatment, the mean maintenance dose ratio between somapacitan (mg/week) and somatropin (mg/day) was predicted to be 8.2 (observed interquartile range of 6.7-9.1).
    1 context sentence
    Summary · context
    Analyses of dosing information, 4364 somapacitan concentration samples and 4880 IGF-I samples from 330 AGHD patients treated with somapacitan in three phase 3 trials.

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.

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