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Study · Randomized controlled trial · n = 184 · 2013

6 results

Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.

Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN

Alimentary pharmacology & therapeutics19 Nov 2012Cited by 147 (Europe PMC)

PMID23163616 (opens in a new tab)DOI10.1111/apt.12147 (opens in a new tab)PepBankPUB-23163616
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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with coeliac disease during gluten challenge, larazotide did not significantly change LAMA ratios versus placebo.

    In plain wordsIn patients with coeliac disease during gluten challenge, larazotide did not significantly change the intestinal permeability measure compared with placebo.

    Peptide
    Larazotide
    Outcome
    No significant changeLactulose-to-mannitol ratio
    Study

    n = 184

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    1, 4, or 8 mg three times daily · oral · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences in LAMA ratios were observed between larazotide acetate and placebo groups.
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 weeks.
  2. 02HumanRandomized controlled trialSafety outcome

    In patients with coeliac disease during gluten challenge, adverse event rates were similar with larazotide and placebo.

    In plain wordsIn patients with coeliac disease during gluten challenge, larazotide and placebo had similar adverse event rates.

    Peptide
    Larazotide
    Outcome
    No significant changeAdverse event rates
    Study

    n = 184

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1, 4, or 8 mg three times daily · oral · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse event rates were similar between larazotide acetate and placebo groups.
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with coeliac disease during gluten challenge, larazotide 1 mg limited GSRS symptoms versus placebo.

    In plain wordsIn patients with coeliac disease during gluten challenge, larazotide 1 mg limited gut symptoms compared with placebo.

    Peptide
    Larazotide
    Outcome
    DecreaseGSRS symptoms
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    1 mg three times daily · oral · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    Larazotide acetate 1-mg limited gluten-induced symptoms measured by GSRS (P = 0.002 vs. placebo).
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with coeliac disease, the antibody ratio over baseline was 5.78 with larazotide 1 mg versus 19.0 with placebo.

    In plain wordsIn patients with coeliac disease, larazotide 1 mg produced a lower antibody ratio than placebo during gluten challenge.

    Peptide
    Larazotide
    Outcome
    DecreaseAnti-tissue transglutaminase IgA ratio
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1 mg three times daily · oral · 6 weeksAs given in this study (human).

    Measurements

    Antibody ratio over baseline
    5.78 ratio
    larazotide 1 mg
    Antibody ratio over baseline
    19 ratio
    placebo

    Source sentences

    Summary
    Mean ratio of anti-tissue transglutaminase IgA levels over baseline was 19.0 in the placebo group compared with 5.78 (P = 0.010), 3.88 (P = 0.005) and 7.72 (P = 0.025) in the larazotide acetate 1-, 4-, and 8-mg groups, respectively.
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with coeliac disease, the antibody ratio over baseline was 3.88 with larazotide 4 mg versus 19.0 with placebo.

    In plain wordsIn patients with coeliac disease, larazotide 4 mg produced a lower antibody ratio than placebo during gluten challenge.

    Peptide
    Larazotide
    Outcome
    DecreaseAnti-tissue transglutaminase IgA ratio
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    4 mg three times daily · oral · 6 weeksAs given in this study (human).

    Measurements

    Antibody ratio over baseline
    3.88 ratio
    larazotide 4 mg
    Antibody ratio over baseline
    19 ratio
    placebo

    Source sentences

    Summary
    Mean ratio of anti-tissue transglutaminase IgA levels over baseline was 19.0 in the placebo group compared with 5.78 (P = 0.010), 3.88 (P = 0.005) and 7.72 (P = 0.025) in the larazotide acetate 1-, 4-, and 8-mg groups, respectively.
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with coeliac disease, the antibody ratio over baseline was 7.72 with larazotide 8 mg versus 19.0 with placebo.

    In plain wordsIn patients with coeliac disease, larazotide 8 mg produced a lower antibody ratio than placebo during gluten challenge.

    Peptide
    Larazotide
    Outcome
    DecreaseAnti-tissue transglutaminase IgA ratio
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    8 mg three times daily · oral · 6 weeksAs given in this study (human).

    Measurements

    Antibody ratio over baseline
    7.72 ratio
    larazotide 8 mg
    Antibody ratio over baseline
    19 ratio
    placebo

    Source sentences

    Summary
    Mean ratio of anti-tissue transglutaminase IgA levels over baseline was 19.0 in the placebo group compared with 5.78 (P = 0.010), 3.88 (P = 0.005) and 7.72 (P = 0.025) in the larazotide acetate 1-, 4-, and 8-mg groups, respectively.
    2 context sentences
    Summary · context
    This exploratory, double-blind, randomised, placebo-controlled study included 184 patients maintaining a GFD before and during the study.
    Summary · context
    After a GFD run-in, patients were randomised to larazotide acetate (1, 4, or 8 mg three times daily) or placebo and received 2.7 grams of gluten daily for 6 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 2NCT00492960

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

9 Meters Biopharma, Inc.n = 171Aug 2007 to Mar 2009

Celiac Disease

Trial pageClinicalTrials.govUpdated 20 Sept 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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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