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Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889473
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

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

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Larazotide acetate Drug: Placebo Dietary Supplement: Gluten 900 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled, dose ranging, multicenter
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Larazotide acetate 1 mg
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: Larazotide acetate
gelatin capsule
Other Names:
  • AT1001
  • INN-202

Dietary Supplement: Gluten 900 mg
gelatin capsule

Placebo Comparator: Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: Placebo
gelatin capsule

Dietary Supplement: Gluten 900 mg
gelatin capsule

Primary Outcome Measures :
  1. Response to gluten [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Anti-transglutaminase [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889473

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United States, California
Study Site
Orange, California, United States
United States, Kansas
Study Site
Topeka, Kansas, United States
United States, Kentucky
Study Site
Lexington, Kentucky, United States
United States, Maryland
Study Site
Hagerstown, Maryland, United States
Study Site
Silver Spring, Maryland, United States
United States, Michigan
Study Site
Chesterfield, Michigan, United States
Study Site
Troy, Michigan, United States
United States, Minnesota
Study Site
Rochester, Minnesota, United States
United States, New York
Study Site
New York, New York, United States
United States, Oklahoma
Study Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Study Site
Paoli, Pennsylvania, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Study Site
Franklin, Tennessee, United States
Canada, Alberta
Study Site
Edmonton, Alberta, Canada
Sponsors and Collaborators
9 Meters Biopharma, Inc.
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Study Director: Francisco Leon, MD, PhD Alba Therapeutics Inc
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Responsible Party: 9 Meters Biopharma, Inc. Identifier: NCT00889473    
Other Study ID Numbers: CLIN1001-006 Part B
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 9 Meters Biopharma, Inc.:
larazotide acetate
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases