Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

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  • participants needed
  • sponsor
    9 Meters Biopharma, Inc.
Updated on 1 September 2021
Anh Thu Nguyen
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abdominal pain
serologic test


To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.


This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Condition Celiac Disease, celiac, celiac sprue
Treatment Matching Placebo, Larazotide
Clinical Study IdentifierNCT03569007
Sponsor9 Meters Biopharma, Inc.
Last Modified on1 September 2021


Yes No Not Sure

Inclusion Criteria

Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
On a gluten-free diet for at least 6 months
Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
Willing to maintain current gluten-free diet throughout participation in the study

Exclusion Criteria

Refractory celiac disease or severe complications of celiac disease
Chronic active GI disease other than celiac disease
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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