Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA

Gastroenterology13 Feb 2015Cited by 178 (Europe PMC)

PMID25683116PMCIDPMC4446229DOI10.1053/j.gastro.2015.02.008PepBankPUB-25683116

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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease on a gluten-free diet, larazotide 0.5 mg reduced symptom scores versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg reduced symptoms more than placebo during a gluten-free diet.
Peptide
Larazotide
Outcome
DecreaseCeliac Disease Gastrointestinal Symptom Rating Scale score
Study
n = 340
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
The primary end point was met with the 0.5-mg dose of larazotide acetate, with fewer symptoms compared with placebo by modified intention to treat (n = 340) (analysis of covariance, P = .022; mixed model for repeated measures, P = .005).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311601
02HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 0.5 mg reduced symptomatic days by 26% versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg reduced symptomatic days by 26% compared with placebo.
Peptide
Larazotide
Outcome
DecreaseSymptomatic days
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Measurements
Decrease in symptomatic days
26%
0.5-mg dose
Source sentences
Summary
The 0.5-mg dose showed an effect on exploratory end points including a 26% decrease in celiac disease patient-reported outcome symptomatic days (P = .017)
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311602
03HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 0.5 mg increased improved symptom days by 31% versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg increased days with improved symptoms by 31% compared with placebo.
Peptide
Larazotide
Outcome
IncreaseImproved symptom days
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Measurements
Increase in improved symptom days
31%
0.5-mg dose
Source sentences
Summary
a 31% increase in improved symptom days (P = .034)
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311603
04HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 0.5 mg improved the response of at least 50% lower weekly abdominal pain for at least 6 of 12 weeks versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg improved the abdominal-pain response measure compared with placebo.
Peptide
Larazotide
Outcome
IncreaseAbdominal pain response
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
a 50% or more reduction from baseline of the weekly average abdominal pain score for 6 or more of 12 weeks of treatment (P = .022)
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311604
05HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 0.5 mg decreased headache symptoms versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg reduced headache symptoms compared with placebo.
Peptide
Larazotide
Outcome
DecreaseHeadache
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Pain · Nervous system and cognition
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
and a decrease in the nongastrointestinal symptoms of headache and tiredness (P = .010).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311605
06HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 0.5 mg decreased tiredness versus placebo.
In plain wordsIn adults with celiac disease, larazotide 0.5 mg reduced tiredness compared with placebo.
Peptide
Larazotide
Outcome
DecreaseTiredness
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Exercise and physical function · Whole body
Studied dose
0.5 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
and a decrease in the nongastrointestinal symptoms of headache and tiredness (P = .010).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311606
07HumanRandomized controlled trialSafety outcome
In adults with celiac disease, larazotide safety was comparable with placebo.
In plain wordsIn adults with celiac disease, larazotide and placebo had comparable safety.
Peptide
Larazotide
Outcome
No significant changeOverall safety
Study
n = 342
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Safety was comparable with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311609
08HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 1 mg did not differ from placebo for any endpoint.
In plain wordsIn adults with celiac disease, larazotide 1 mg did not differ from placebo for any measured endpoint.
Peptide
Larazotide
Outcome
No significant changeEfficacy endpoints
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
1 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
The 1- and 2-mg doses were no different than placebo for any end point.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311607
09HumanRandomized controlled trialEfficacy outcome
In adults with celiac disease, larazotide 2 mg did not differ from placebo for any endpoint.
In plain wordsIn adults with celiac disease, larazotide 2 mg did not differ from placebo for any measured endpoint.
Peptide
Larazotide
Outcome
No significant changeEfficacy endpoints
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
2 mg 3 times daily · 12 weeksAs given in this study (human).
Source sentences
Summary
The 1- and 2-mg doses were no different than placebo for any end point.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study.
Summary · context
The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase.
Report a problemFND-2568311608

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 2NCT01396213

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

9 Meters Biopharma, Inc.n = 3427 Nov 2011 to 20 Aug 2013

Celiac Disease

Trial page ClinicalTrials.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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
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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