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Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00889473
Enrollment
42
Registered
2009-04-29
Start date
2009-04-30
Completion date
2010-04-30
Last updated
2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

larazotide acetate, gluten

Brief summary

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

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

DRUGLarazotide acetate

gelatin capsule

DRUGPlacebo

gelatin capsule

DIETARY_SUPPLEMENTGluten 900 mg

gelatin capsule

Sponsors

9 Meters Biopharma, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double-blind

Intervention model description

randomized, double-blind, placebo-controlled, dose ranging, multicenter

Eligibility

Sex/Gender
ALL
Age
18 Years to 72 Years
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

Design outcomes

Primary

MeasureTime frame
Response to gluten6 weeks

Secondary

MeasureTime frame
Anti-transglutaminase6 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026