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Study · Non-randomized trial · n = 3 · 2026

8 results

Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study.

Masumoto K, Muto M, Sasaki T, Shikamura M, Tanaka T, Sakui S, Miyamoto M, Nakano H, Kondo T, Ieiri S

Pediatrics international : official journal of the Japan Pediatric Society1 Jan 2026Cited by 2 (Europe PMC)

PMID41454663 (opens in a new tab)PMCIDPMC12743259 (opens in a new tab)DOI10.1111/ped.70301 (opens in a new tab)PepBankPUB-41454663
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Summary

BackgroundPatients with short bowel syndrome (SBS)-associated intestinal failure (SBS-IF) are dependent on parenteral support (PS). In Japan, teduglutide is the only GLP-2 analog medicine indicated for these patients. There are limited data for pediatric patients, especially those with a low body weight. This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.MethodsThis phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF. Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up). Adverse events, changes in PS requirements, and growth parameters were assessed.ResultsThree patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks. All patients experienced treatment-emergent adverse events (TEAEs), but none were related to the study drug or led to death or treatment discontinuation. Clinically meaningful reductions in mean PS volume (13.1%) and mean PS caloric intake (46.6%) were observed at the end of treatment from baseline. One patient achieved a reduction in PS volume of ≥20% at the end of treatment from baseline. Growth parameters showed increases in weight and height/length-for-age z-scores at the end of treatment from baseline.ConclusionIn the three patients with SBS-IF who weighed less than 10 kg, no new safety signals were observed following teduglutide treatment. Clinically meaningful reductions in PS were noted and there was no adverse impact on growth parameters.Trial registrationClinicalTrials.gov registration number: NCT05027308.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In Japanese children under 10 kg with SBS-IF, all three teduglutide recipients experienced TEAEs, none considered study-drug-related.

    In plain wordsIn children under 10 kg with short bowel syndrome, all three teduglutide recipients had adverse events, none considered drug-related.

    Peptide
    Teduglutide
    Outcome
    Not applicableTreatment-emergent adverse events
    Study

    n = 3

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Source sentences

    Summary
    All patients experienced treatment-emergent adverse events (TEAEs), but none were related to the study drug or led to death or treatment discontinuation.
    4 context sentences
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
  2. 02HumanNon-randomized trialSafety outcome

    In Japanese children under 10 kg with SBS-IF, no TEAEs during teduglutide treatment led to death.

    In plain wordsIn children under 10 kg with short bowel syndrome, no adverse events during teduglutide treatment led to death.

    Peptide
    Teduglutide
    Outcome
    Not applicableTEAEs leading to death
    Study

    n = 3

    Outcome group
    Mortality · Whole body
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Source sentences

    Summary
    All patients experienced treatment-emergent adverse events (TEAEs), but none were related to the study drug or led to death or treatment discontinuation.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In Japanese children under 10 kg with SBS-IF, no TEAEs during teduglutide treatment led to discontinuation.

    In plain wordsIn children under 10 kg with short bowel syndrome, no adverse events during teduglutide treatment led to treatment discontinuation.

    Peptide
    Teduglutide
    Outcome
    Not applicableTEAEs leading to treatment discontinuation
    Study

    n = 3

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Source sentences

    Summary
    All patients experienced treatment-emergent adverse events (TEAEs), but none were related to the study drug or led to death or treatment discontinuation.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  4. 04HumanNon-randomized trialEfficacy outcome

    In Japanese children under 10 kg with SBS-IF, mean PS volume decreased 13.1% from baseline at teduglutide treatment end.

    In plain wordsIn children under 10 kg with short bowel syndrome, mean intravenous support volume decreased 13.1% from baseline after teduglutide.

    Peptide
    Teduglutide
    Outcome
    DecreaseMean parenteral support volume
    Study

    n = 3

    Comparator
    Baseline
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Measurements

    Mean PS volume reduction
    13.1%
    end of treatment vs baseline

    Source sentences

    Summary
    Clinically meaningful reductions in mean PS volume (13.1%) and mean PS caloric intake (46.6%) were observed at the end of treatment from baseline.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Japanese children under 10 kg with SBS-IF, mean PS caloric intake decreased 46.6% from baseline at teduglutide treatment end.

    In plain wordsIn children under 10 kg with short bowel syndrome, mean intravenous calorie intake decreased 46.6% from baseline after teduglutide.

    Peptide
    Teduglutide
    Outcome
    DecreaseMean parenteral support caloric intake
    Study

    n = 3

    Comparator
    Baseline
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Measurements

    Mean PS caloric intake reduction
    46.6%
    end of treatment vs baseline

    Source sentences

    Summary
    Clinically meaningful reductions in mean PS volume (13.1%) and mean PS caloric intake (46.6%) were observed at the end of treatment from baseline.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Japanese children under 10 kg with SBS-IF, one teduglutide recipient achieved a PS volume reduction of ≥20% from baseline.

    In plain wordsIn children under 10 kg with short bowel syndrome, one teduglutide recipient reduced intravenous support volume by at least 20%.

    Peptide
    Teduglutide
    Outcome
    DecreasePS volume reduction of at least 20%
    Study

    n = 3

    Comparator
    Baseline
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Measurements

    Patients with PS volume reduction
    1 patients
    end of treatment vs baseline
    PS volume reduction threshold
    ≥ 20%
    end of treatment vs baseline

    Source sentences

    Summary
    One patient achieved a reduction in PS volume of ≥20% at the end of treatment from baseline.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  7. 07HumanNon-randomized trialEfficacy outcome

    In Japanese children under 10 kg with SBS-IF, weight-for-age z-scores increased from baseline at teduglutide treatment end.

    In plain wordsIn children under 10 kg with short bowel syndrome, weight-for-age scores increased from baseline after teduglutide.

    Peptide
    Teduglutide
    Outcome
    IncreaseWeight-for-age z-score
    Study

    n = 3

    Comparator
    Baseline
    Outcome group
    Linear growth · Metabolic and weight
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Source sentences

    Summary
    Growth parameters showed increases in weight and height/length-for-age z-scores at the end of treatment from baseline.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.
  8. 08HumanNon-randomized trialEfficacy outcome

    In Japanese children under 10 kg with SBS-IF, height/length-for-age z-scores increased from baseline at teduglutide treatment end.

    In plain wordsIn children under 10 kg with short bowel syndrome, height or length-for-age scores increased from baseline after teduglutide.

    Peptide
    Teduglutide
    Outcome
    IncreaseHeight/length-for-age z-score
    Study

    n = 3

    Comparator
    Baseline
    Outcome group
    Linear growth · Musculoskeletal
    Studied dose
    0.05 mg/kg/day · subcutaneous · Mean exposure 48.9 weeksAs given in this study (human).

    Source sentences

    Summary
    Growth parameters showed increases in weight and height/length-for-age z-scores at the end of treatment from baseline.
    4 context sentences
    Summary · context
    This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.
    Summary · context
    This phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF.
    Summary · context
    Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up).
    Summary · context
    Three patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks.

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 3Results postedNCT05027308

A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

Takedan = 34 Jan 2022 to 27 Sept 2023

Short Bowel Syndrome

Trial pageClinicalTrials.govUpdated 16 May 2024

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, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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