Skip to main content
OpenTrials
Completed

NCT Number: NCT00492960

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

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Edmonton, Alberta, Canada

Loading trial locations.

About this study

This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larazotide acetate

Drug

gelatin capsules

Other names: AT-1001, INN-202

Placebo

Drug

gelatin capsules

900 mg gluten

Dietary Supplement

gelatin capsules

Primary outcomes

  1. Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.

    Time frame: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.

    The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

Secondary outcomes

  1. Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals

    Time frame: Up to 6 weeks

    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results

  2. To prospectively validate a composite, weighted index of celiac disease activity

    Time frame: GSRS was completed weekly throughout the study.

    Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire

Sponsors and collaborators

Lead sponsor

9 Meters Biopharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 27, 2007
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.