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Study · Randomized controlled trial · 2022

4 results

Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial.

Hvistendahl MK, Naimi RM, Hansen SH, Rehfeld JF, Kissow H, Pedersen J, Dragsted LO, Sonne DP, Knop FK, Jeppesen PB

JPEN. Journal of parenteral and enteral nutrition1 Sept 2021Cited by 14 (Europe PMC)

PMID34287979 (opens in a new tab)DOI10.1002/jpen.2224 (opens in a new tab)PepBankPUB-34287979
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with short bowel syndrome, glepaglutide 10 mg increased the median postprandial FGF19 response by 150 h × ng/L from baseline (P = 0.001).

    In plain wordsIn patients with short bowel syndrome, glepaglutide increased postprandial FGF19 response from baseline.

    Peptide
    Glepaglutide
    Outcome
    IncreasePostprandial FGF19 response
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    10 mg daily · subcutaneous · 3 weeksAs given in this study (human).

    Measurements

    Change in postprandial FGF19 response (AUC 0-2h)
    150 h × ng/L
    10-mg dose, median change from baseline

    Source sentences

    Summary
    Compared with baseline, the median (interquartile range) postprandial response (area under the curve 0-2h) of FGF19 increased by 150 h × ng/L (41, 195; P = 0.001) and C4 decreased by 82 h × µg/L (-169, -28; p = 0.010) in the 10-mg dose.
    1 context sentence
    Summary · context
    In a single-center, double-blinded, dose-finding, crossover phase 2 trial, 18 patients with SBS were randomly assigned to 2 of 3 treatment arms (0.1, 1, and 10 mg) with daily subcutaneous injections of glepaglutide for 3 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with short bowel syndrome, glepaglutide 10 mg decreased the median postprandial C4 response by 82 h × µg/L from baseline (p = 0.010).

    In plain wordsIn patients with short bowel syndrome, glepaglutide decreased postprandial C4 response from baseline.

    Peptide
    Glepaglutide
    Outcome
    DecreasePostprandial C4 response
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    10 mg daily · subcutaneous · 3 weeksAs given in this study (human).

    Measurements

    Change in postprandial C4 response (AUC 0-2h)
    82 h × µg/L
    10-mg dose, median decrease from baseline

    Source sentences

    Summary
    Compared with baseline, the median (interquartile range) postprandial response (area under the curve 0-2h) of FGF19 increased by 150 h × ng/L (41, 195; P = 0.001) and C4 decreased by 82 h × µg/L (-169, -28; p = 0.010) in the 10-mg dose.
    1 context sentence
    Summary · context
    In a single-center, double-blinded, dose-finding, crossover phase 2 trial, 18 patients with SBS were randomly assigned to 2 of 3 treatment arms (0.1, 1, and 10 mg) with daily subcutaneous injections of glepaglutide for 3 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with short bowel syndrome, FXR gene expression did not change from baseline in any glepaglutide dose group.

    In plain wordsIn patients with short bowel syndrome, FXR gene expression did not change from baseline in any glepaglutide dose group.

    Peptide
    Glepaglutide
    Outcome
    No significant changeFXR gene expression
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    0.1, 1, and 10 mg daily · subcutaneous · 3 weeksAs given in this study (human).

    Source sentences

    Summary
    FXR gene expression did not change in any of the groups.
    1 context sentence
    Summary · context
    In a single-center, double-blinded, dose-finding, crossover phase 2 trial, 18 patients with SBS were randomly assigned to 2 of 3 treatment arms (0.1, 1, and 10 mg) with daily subcutaneous injections of glepaglutide for 3 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with short bowel syndrome, alkaline phosphatase significantly decreased during glepaglutide treatment.

    In plain wordsIn patients with short bowel syndrome, alkaline phosphatase significantly decreased during glepaglutide treatment.

    Peptide
    Glepaglutide
    Outcome
    DecreaseAlkaline phosphatase
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · subcutaneous · 3 weeksAs given in this study (human).

    Source sentences

    Summary
    Alkaline phosphatase significantly decreased.
    1 context sentence
    Summary · context
    In a single-center, double-blinded, dose-finding, crossover phase 2 trial, 18 patients with SBS were randomly assigned to 2 of 3 treatment arms (0.1, 1, and 10 mg) with daily subcutaneous injections of glepaglutide for 3 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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT02690025

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Zealand Pharman = 18Feb 2016 to May 2017

Short Bowel Syndrome

Trial pageClinicalTrials.govUpdated 21 Jun 2017

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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