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Study · Randomized controlled trial · n = 32 · 2017

14 results

Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial.

Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Sävendahl L

Clinical endocrinology8 Aug 2017Cited by 48 (Europe PMC)

PMID28656605 (opens in a new tab)DOI10.1111/cen.13409 (opens in a new tab)PepBankPUB-28656605
Publisher pagePubMedAsk about this study
Jump to 14 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In children with GHD, AE types and frequencies showed no apparent treatment-dependent pattern with somapacitan versus daily GH.

    In plain wordsIn children with GHD, adverse event types and frequencies showed no apparent pattern distinguishing somapacitan from daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeAdverse event type and frequency
    Study

    n = 32

    Comparator
    Daily GH
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    Adverse events were all mild, and there were no apparent treatment-dependent patterns in type or frequency.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  2. 02HumanNon-randomized trialSafety outcome

    In children with GHD, all adverse events after somapacitan were mild.

    In plain wordsIn children with GHD, all adverse events after somapacitan were mild.

    Peptide
    Somapacitan
    Outcome
    Not applicableAdverse event severity
    Study

    n = 24

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    Adverse events were all mild, and there were no apparent treatment-dependent patterns in type or frequency.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  3. 03HumanNon-randomized trialSafety outcome

    In children with GHD, four mild transient injection-site reactions occurred in three of 24 somapacitan recipients.

    In plain wordsIn children with GHD, three of 24 somapacitan recipients had four mild temporary injection-site reactions.

    Peptide
    Somapacitan
    Outcome
    Not applicableInjection-site reactions
    Study

    n = 24

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Measurements

    Injection site reactions
    4 reactions
    somapacitan-treated children
    Children with injection site reactions
    3 children of 24
    somapacitan-treated children

    Source sentences

    Summary
    Four mild transient injection site reactions were reported in three of 24 children treated with somapacitan.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  4. 04HumanNon-randomized trialSafety outcome

    In children with GHD, no anti-somapacitan antibodies were detected after somapacitan.

    In plain wordsIn children with GHD, no antibodies against somapacitan were detected after treatment.

    Peptide
    Somapacitan
    Outcome
    Not applicableAnti-somapacitan antibodies
    Study

    n = 24

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    No antisomapacitan/anti-human growth hormone (hGH) antibodies were detected.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  5. 05HumanNon-randomized trialSafety outcome

    In children with GHD, no anti-hGH antibodies were detected after somapacitan.

    In plain wordsIn children with GHD, no antibodies against human growth hormone were detected after somapacitan.

    Peptide
    Somapacitan
    Outcome
    Not applicableAnti-hGH antibodies
    Study

    n = 24

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    No antisomapacitan/anti-human growth hormone (hGH) antibodies were detected.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  6. 06HumanNon-randomized trialPharmacokinetics

    In children with GHD, somapacitan serum concentrations increased with dose in a nonlinear manner.

    In plain wordsIn children with GHD, blood somapacitan concentrations increased nonlinearly as the dose increased.

    Peptide
    Somapacitan
    Outcome
    IncreaseDose-concentration relationship
    Study

    n = 24

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Measurements

    Maximum concentration range
    21.8 to 458.4 ng/mL
    0.02 to 0.16 mg/kg single dose

    Source sentences

    Summary
    Mean serum concentrations of somapacitan increased in a dose-dependent but nonlinear manner: maximum concentration ranged from 21.8 ng/mL (0.02 mg/kg dose) to 458.4 ng/mL (0.16 mg/kg dose).
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  7. 07HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGF-I increased dose dependently after somapacitan.

    In plain wordsIn children with GHD, IGF-I increased as the somapacitan dose increased.

    Peptide
    Somapacitan
    Outcome
    IncreaseIGF-I concentration
    Study

    n = 24

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16 mg/kg.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  8. 08HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGFBP-3 increased dose dependently after somapacitan.

    In plain wordsIn children with GHD, IGFBP-3 increased as the somapacitan dose increased.

    Peptide
    Somapacitan
    Outcome
    IncreaseIGFBP-3 concentration
    Study

    n = 24

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16 mg/kg.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  9. 09HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGF-I SDS change increased dose dependently after somapacitan, with the greatest change at 0.16 mg/kg.

    In plain wordsIn children with GHD, IGF-I score increases grew with somapacitan dose and were greatest at 0.16 mg/kg.

    Peptide
    Somapacitan
    Outcome
    IncreaseIGF-I SDS change
    Study

    n = 24

    Comparator
    Baseline
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16 mg/kg.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  10. 10HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGFBP-3 SDS change increased dose dependently after somapacitan, with the greatest change at 0.16 mg/kg.

    In plain wordsIn children with GHD, IGFBP-3 score increases grew with somapacitan dose and were greatest at 0.16 mg/kg.

    Peptide
    Somapacitan
    Outcome
    IncreaseIGFBP-3 SDS change
    Study

    n = 24

    Comparator
    Baseline
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Source sentences

    Summary
    IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16 mg/kg.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  11. 11HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGF-I SDS remained between -2 and +2 except for the peak after somapacitan 0.08 mg/kg.

    In plain wordsIn children with GHD, IGF-I scores stayed between -2 and +2 except for the peak after somapacitan 0.08 mg/kg.

    Peptide
    Somapacitan
    Outcome
    Not applicableIGF-I SDS range
    Study

    n = 24

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Measurements

    IGF-I SDS range
    −2 to 2 SDS
    all doses except peak at 0.08 mg/kg

    Source sentences

    Summary
    IGF-I SDS values were between -2 and +2 SDS, except for peak IGF-I SDS with 0.08 mg/kg somapacitan.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  12. 12HumanNon-randomized trialEfficacy outcome

    In children with GHD, IGF-I SDS remained above baseline for at least 1 week after somapacitan dosing.

    In plain wordsIn children with GHD, IGF-I scores stayed above baseline for at least 1 week after somapacitan.

    Peptide
    Somapacitan
    Outcome
    IncreaseDuration of IGF-I SDS elevation
    Study

    n = 24

    Comparator
    Baseline
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.02-0.16 mg/kg · Single doseAs given in this study (human).

    Measurements

    Duration of IGF-I SDS above baseline
    ≥ 1 week
    after single somapacitan dose

    Source sentences

    Summary
    Postdosing, IGF-I SDS remained above baseline levels for at least 1 week.
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  13. 13HumanNon-randomized trialPharmacokinetics

    In children with GHD, maximum somapacitan serum concentration was 21.8 ng/mL after 0.02 mg/kg.

    In plain wordsIn children with GHD, peak blood somapacitan concentration was 21.8 ng/mL after 0.02 mg/kg.

    Peptide
    Somapacitan
    Outcome
    Not applicableMaximum serum concentration
    Study

    n = 6

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.02 mg/kg · Single doseAs given in this study (human).

    Measurements

    Maximum concentration
    21.8 ng/mL
    0.02 mg/kg

    Source sentences

    Summary
    Mean serum concentrations of somapacitan increased in a dose-dependent but nonlinear manner: maximum concentration ranged from 21.8 ng/mL (0.02 mg/kg dose) to 458.4 ng/mL (0.16 mg/kg dose).
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.
  14. 14HumanNon-randomized trialPharmacokinetics

    In children with GHD, maximum somapacitan serum concentration was 458.4 ng/mL after 0.16 mg/kg.

    In plain wordsIn children with GHD, peak blood somapacitan concentration was 458.4 ng/mL after 0.16 mg/kg.

    Peptide
    Somapacitan
    Outcome
    Not applicableMaximum serum concentration
    Study

    n = 6

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.16 mg/kg · Single doseAs given in this study (human).

    Measurements

    Maximum concentration
    458.4 ng/mL
    0.16 mg/kg

    Source sentences

    Summary
    Mean serum concentrations of somapacitan increased in a dose-dependent but nonlinear manner: maximum concentration ranged from 21.8 ng/mL (0.02 mg/kg dose) to 458.4 ng/mL (0.16 mg/kg dose).
    2 context sentences
    Summary · context
    Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).
    Summary · context
    Thirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16 mg/kg; n=6 each), or once-daily Norditropin® SimpleXx® (0.03 mg/kg; n=2 each) for 7 days.

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01973244

A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Novo Nordisk A/Sn = 3216 Dec 2013 to 4 Nov 2014

Growth Hormone Disorder · Growth Hormone Deficiency in Children

Trial pageClinicalTrials.govUpdated 24 Dec 2020

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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