DRUG
Larazotide acetate
gelatin capsule
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
Status
Completed
Phase
Phase 2
Enrollment
42
Locations
15
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease
Full detailed description
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
Interventions
Treatment arms and agents.
DRUG
Placebo
gelatin capsule
DIETARY_SUPPLEMENT
Gluten 900 mg
gelatin capsule
Timeline
From registration to results.
First posted
Apr 29, 2009
Study start
Apr 2009
Primary completion
Nov 2009
Study completion
Apr 2010
Results posted
Not reported
Registry updated
Sep 20, 2017
Outcomes
What the study measures.
Primary outcomes
Response to gluten
Time frame · 6 weeks
Secondary outcomes
Anti-transglutaminase
Time frame · 6 weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 72 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months * Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU. * BMI between 18.5 and 38, inclusive. Exclusion Criteria * Has chronic active GI disease other than celiac disease * Has diabetes (Type 1 or Type 2). * Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study. * Has hemoglobin value below 8.5 g/dL
Study locations
15 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Study Site
Orange, California, United States
Study Site
Topeka, Kansas, United States
Study Site
Lexington, Kentucky, United States
Study Site
Hagerstown, Maryland, United States
Study Site
Silver Spring, Maryland, United States
Study Site
Chesterfield, Michigan, United States
Study Site
Troy, Michigan, United States
Study Site
Rochester, Minnesota, United States
Study Site
New York, New York, United States
Study Site
Oklahoma City, Oklahoma, United States
Study Site
Paoli, Pennsylvania, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
Study Site
Franklin, Tennessee, United States
Study Site
Edmonton, Alberta, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Larazotide.
NCT IDStudyPhase / statusEnrollmentUpdated
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A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants
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Recruiting
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AT1001 for the Treatment of Long COVID
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Phase 2
Active, not recruiting
107
2026-05
Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease
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Phase 3
Completed
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2026-02
Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease
Amicus Therapeutics · Fabry Disease
Not applicable
Available
—
2025-07
AT1001 for the Treatment of COVID-19 Related MIS-C
Massachusetts General Hospital · Covid19 · Multisystem Inflammatory Syndrome in Children
Phase 2
Terminated
12
2024-06
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
9 Meters Biopharma, Inc. · Celiac Disease
Phase 3
Terminated
307
2022-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.