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A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex in Adults With Growth Hormone Deficiency

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Trial Profile

A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex in Adults With Growth Hormone Deficiency

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Somapacitan (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Adverse reactions
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 17 Apr 2021 Pooled modelling analysis of data from ClinicalTrials.gov identifiers NCT01973244, NCT00936403 and NCT01706783 published in the Clinical Pharmacokinetics
    • 12 Dec 2020 Results of a pooled analysis (NCT01514500, NCT01706783 and ) data from assessing the pharmacokinetic/pharmacodynamics model published in the Journal of Clinical Endocrinology and Metabolism
    • 18 Apr 2018 Results assessing pooled pharmacokinetic/pharmacodynamic modeling analysis of data from three phase I studies published in the Clinical Pharmacokinetics.
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