Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03569007 |
Recruitment Status :
Recruiting
First Posted : June 26, 2018
Last Update Posted : August 26, 2021
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Celiac Disease | Drug: Larazotide Drug: Matching Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 630 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD |
Actual Study Start Date : | May 29, 2019 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Larazotide 0.25 mg
Larazotide 0.25 mg capsules TID
|
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202 |
Active Comparator: Larazotide 0.50 mg
Larazotide 0.50 mg capsules TID
|
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202 |
Placebo Comparator: Placebo
Matching placebo capsules TID
|
Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Name: placebo |
- Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]Reduction in CeD PRO Abdominal Domain scores

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 ClinicalTrials.gov identifier (NCT number): NCT03569007
Contact: Anh Thu Nguyen | 919-275-1933 | joinstudy@9meters.com |

United States, Alabama | |
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Saraland, Alabama, United States, 36571 | |
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Scottsdale, Arizona, United States, 85251 | |
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Tucson, Arizona, United States, 85712 | |
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Tucson, Arizona, United States, 85745 | |
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North Little Rock, Arkansas, United States, 72117 | |
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Bellflower, California, United States, 90706 | |
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Beverly Hills, California, United States, 90211 | |
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Canoga Park, California, United States, 91303 | |
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Corona, California, United States, 92879 | |
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Garden Grove, California, United States, 92845 | |
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Lancaster, California, United States, 93534 | |
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Los Gatos, California, United States, 95032 | |
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Northridge, California, United States, 91324 | |
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Poway, California, United States, 92064 | |
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Rialto, California, United States, 92377 | |
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San Diego, California, United States, 92013 | |
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San Diego, California, United States, 92103 | |
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San Francisco, California, United States, 94102 | |
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Walnut Creek, California, United States, 94598 | |
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Bridgeport, Connecticut, United States, 06606 | |
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Hamden, Connecticut, United States, 06518 | |
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Stamford, Connecticut, United States, 06905 | |
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Boynton Beach, Florida, United States, 33472 | |
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Clearwater, Florida, United States, 33756 | |
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Inverness, Florida, United States, 34452 | |
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Lakewood Ranch, Florida, United States, 34211 | |
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Miami, Florida, United States, 33133 | |
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Orlando, Florida, United States, 32803 | |
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Orlando, Florida, United States, 32825 | |
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Port Orange, Florida, United States, 32127 | |
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Atlanta, Georgia, United States, 30328 | |
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Columbus, Georgia, United States, 31904 | |
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Macon, Georgia, United States, 31201 | |
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Stockbridge, Georgia, United States, 30281 | |
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Stone Mountain, Georgia, United States, 30083 | |
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Sugar Hill, Georgia, United States, 30518 | |
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Boise, Idaho, United States, 83706 | |
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Idaho Falls, Idaho, United States, 83404 | |
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Arlington Heights, Illinois, United States, 60005 | |
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Fairview Heights, Illinois, United States, 62208 | |
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Melrose Park, Illinois, United States, 60160 | |
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Morton, Illinois, United States, 61550 | |
United States, Iowa | |
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Clive, Iowa, United States, 50325 | |
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Iowa City, Iowa, United States, 52242 | |
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West Des Moines, Iowa, United States, 50266 | |
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Topeka, Kansas, United States, 66606 | |
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Lexington, Kentucky, United States, 40509 | |
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Lexington, Kentucky, United States, 40536 | |
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Louisville, Kentucky, United States, 40202 | |
United States, Louisiana | |
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Crowley, Louisiana, United States, 70526 | |
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Metairie, Louisiana, United States, 70006 | |
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New Orleans, Louisiana, United States, 70115 | |
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New Orleans, Louisiana, United States, 70125 | |
United States, Maryland | |
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Baltimore, Maryland, United States, 21208 | |
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Catonsville, Maryland, United States, 21228 | |
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Columbia, Maryland, United States, 21045 | |
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Hagerstown, Maryland, United States, 21742 | |
United States, Massachusetts | |
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Boston, Massachusetts, United States, 02114 | |
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Fall River, Massachusetts, United States, 02723 | |
United States, Michigan | |
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Chesterfield, Michigan, United States, 48047 | |
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Rochester, Michigan, United States, 48307 | |
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Wyoming, Michigan, United States, 49519 | |
United States, Minnesota | |
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Maplewood, Minnesota, United States, 55117 | |
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Rochester, Minnesota, United States, 55905 | |
United States, Mississippi | |
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Petal, Mississippi, United States, 39465 | |
United States, Missouri | |
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Jefferson City, Missouri, United States, 65109 | |
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Saint Louis, Missouri, United States, 63141 | |
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Omaha, Nebraska, United States, 68114 | |
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Omaha, Nebraska, United States, 68134 | |
United States, Nevada | |
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Las Vegas, Nevada, United States, 89106 | |
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Las Vegas, Nevada, United States, 89109 | |
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Las Vegas, Nevada, United States, 89119 | |
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Las Vegas, Nevada, United States, 89128 | |
United States, New Hampshire | |
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Portsmouth, New Hampshire, United States, 03801 | |
United States, New Jersey | |
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Ocean Township, New Jersey, United States, 07712 | |
United States, New Mexico | |
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Albuquerque, New Mexico, United States, 87102 | |
United States, New York | |
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Great Neck, New York, United States, 11023 | |
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Mineola, New York, United States, 11501 | |
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New Windsor, New York, United States, 12553 | |
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New York, New York, United States, 10016 | |
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New York, New York, United States, 10032 | |
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New York, New York, United States, 11419 | |
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Poughkeepsie, New York, United States, 12601 | |
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Williamsville, New York, United States, 14221 | |
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Asheville, North Carolina, United States, 28801 | |
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Charlotte, North Carolina, United States, 28207 | |
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Concord, North Carolina, United States, 28025 | |
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Greenville, North Carolina, United States, 27834 | |
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Salisbury, North Carolina, United States, 28144 | |
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Winston-Salem, North Carolina, United States, 27103 | |
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Cincinnati, Ohio, United States, 45215 | |
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Cincinnati, Ohio, United States, 45219 | |
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Cleveland, Ohio, United States, 44122 | |
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Columbus, Ohio, United States, 43214 | |
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Dayton, Ohio, United States, 45415 | |
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Dayton, Ohio, United States, 45419 | |
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Mentor, Ohio, United States, 44060 | |
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Poland, Ohio, United States, 44514 | |
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Norman, Oklahoma, United States, 73071 | |
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Oklahoma City, Oklahoma, United States, 73112 | |
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Tulsa, Oklahoma, United States, 74104 | |
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Happy Valley, Oregon, United States, 97086 | |
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Hershey, Pennsylvania, United States, 17033 | |
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Philadelphia, Pennsylvania, United States, 19107 | |
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Sayre, Pennsylvania, United States, 18840 | |
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Scranton, Pennsylvania, United States, 18508 | |
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Lincoln, Rhode Island, United States, 02865 | |
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Warwick, Rhode Island, United States, 02886 | |
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Mount Pleasant, South Carolina, United States, 29464 | |
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West Columbia, South Carolina, United States, 29169 | |
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Sioux Falls, South Dakota, United States, 57108 | |
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Chattanooga, Tennessee, United States, 37421 | |
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Nashville, Tennessee, United States, 37212 | |
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Austin, Texas, United States, 77024 | |
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Austin, Texas, United States, 78704 | |
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Austin, Texas, United States, 78726 | |
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Austin, Texas, United States, 78745 | |
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Cypress, Texas, United States, 77429 | |
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Dallas, Texas, United States, 75224 | |
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DeSoto, Texas, United States, 75115 | |
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Garland, Texas, United States, 75044 | |
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Harlingen, Texas, United States, 78550 | |
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Houston, Texas, United States, 77025 | |
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Houston, Texas, United States, 77058 | |
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Houston, Texas, United States, 77084 | |
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McAllen, Texas, United States, 78503 | |
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San Antonio, Texas, United States, 78215 | |
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Sugar Land, Texas, United States, 77476 | |
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Sugar Land, Texas, United States, 77479 | |
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Victoria, Texas, United States, 77904 | |
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Ogden, Utah, United States, 84403 | |
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Ogden, Utah, United States, 84405 | |
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Saint George, Utah, United States, 84790 | |
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Salt Lake City, Utah, United States, 84124 | |
United States, Virginia | |
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Chesapeake, Virginia, United States, 23320 | |
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Fairfax, Virginia, United States, 22031 | |
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Gainesville, Virginia, United States, 20155 | |
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Lansdowne Town Center, Virginia, United States, 20176 | |
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Lynchburg, Virginia, United States, 24502 | |
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Norfolk, Virginia, United States, 23507 | |
United States, Washington | |
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Bellevue, Washington, United States, 98007 | |
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Spokane, Washington, United States, 99202 | |
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Spokane, Washington, United States, 99204 | |
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Vancouver, Washington, United States, 98664 | |
United States, Wisconsin | |
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Wauwatosa, Wisconsin, United States, 53226 |
Responsible Party: | 9 Meters Biopharma, Inc. |
ClinicalTrials.gov Identifier: | NCT03569007 |
Other Study ID Numbers: |
CeD-LA-3001 |
First Posted: | June 26, 2018 Key Record Dates |
Last Update Posted: | August 26, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |