Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
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ClinicalTrials.gov Identifier: NCT00362856 |
Recruitment Status :
Completed
First Posted : August 10, 2006
Last Update Posted : September 12, 2017
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Condition or disease | Intervention/treatment | Phase |
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Celiac Disease | Drug: larazotide acetate Drug: Placebo | Phase 2 |
CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm, multicenter study with a gluten challenge. The objects were multiple dose safety and tolerance; efficacy (intestinal permeability [change in urinary LAMA ratio] and disease signs and symptoms) following gluten challenge.
Following a 21-day screening period, subjects were randomized to one of seven treatments groups: four groups received larazotide acetate (0.25 mg, 1 mg, 4 mg or 8 mg TID) along with an 800 mg gluten challenge, one group received placebo with an 800 mg gluten challenge, a safety control arm received the highest dose of larazotide acetate (8 mg TID) and gluten placebo and the last group received drug placebo and gluten placebo. The gluten challenge was administered as capsules (800 mg TID) with each main meal for a total of 2.4 g daily. Drug or drug placebo was administered TID 15 minutes prior to each main meal. Subjects received their assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up visit one week later (Day 21). Subjects remained on their gluten-free diet for the duration of the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 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 2a, 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 Gluten Challenge. |
Actual Study Start Date : | September 13, 2006 |
Actual Primary Completion Date : | March 6, 2007 |
Actual Study Completion Date : | March 6, 2007 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo + Gluten
placebo TID + gluten 800 mg TID administered orally in capsules
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Drug: Placebo
capsule |
Placebo Comparator: Placebo + Gluten placebo
placebo TID + gluten placebo TID administered orally in capsules
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Drug: Placebo
capsule |
Larazotide acetate 8 mg + Gluten placebo
Safety Control Arm. Larazotide acetate 8 mg TID + gluten placebo TID administered orally in capsules
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Drug: larazotide acetate
capsule
Other Names:
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Active Comparator: Larazotide acetate 0.25 mg + Gluten
Larazotide acetate 0.25 mg TID + gluten 800 mg TID administered orally in capsules
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Drug: larazotide acetate
capsule
Other Names:
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Active Comparator: Larazotide acetate 1 mg + Gluten
Larazotide acetate 1 mg TID + gluten 800 mg TID administered orally in capsules
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Drug: larazotide acetate
capsule
Other Names:
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Active Comparator: Larazotide acetate 4 mg + Gluten
Larazotide acetate 4 mg TID + gluten 800 mg TID administered orally in capsules
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Drug: larazotide acetate
capsule
Other Names:
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Active Comparator: Larazotide acetate 8 mg + Gluten
Larazotide acetate 8 mg TID + gluten 800 mg TID administered orally in capsules
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Drug: larazotide acetate
capsule
Other Names:
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- To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet. [ Time Frame: Safety measurements were performed at Screening and at Day 0, 7, 14, and 21 ('End of Study'). Any change from baseline value was calculated at each subsequent visit until "End of Study" (Day 21). ]Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG
- To evaluate the efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge [ Time Frame: On Days 0, 6, 13, and 20 subjects drank a solution of lactulose and mannitol. Subject's urine was collected during the day on Day 0 and overnight prior to subsequent visits and analyzed for LAMA recoveries via standardized methodologies. ]The primary efficacy outcome was the Day 0-to-Day 14 change in urinary LAMA ratio ( a measure of intestinal permeability) as a response to gluten
- Changes in daily and weekly reported health outcomes [ Time Frame: Symptom diary - daily; PGWBI - weekly; GSRS - weekly ]Health outcomes were assessed using a daily symptom diary; a weekly PGWBI and a weekly GSRS
- Changes in urinary LAMA ratios between Day 0 to Day 7 [ Time Frame: See Primary Outcome Measure No. 2 ]See Primary Outcome Measure No. 2
- Changes in urinary lactulose fractional excretion between Day 0 to Day 7 to Day 14 [ Time Frame: See Primary Outcome Measure No. 2 ]See Primary Outcome Measure No. 2
- Changes in urinary mannitol fractional excretion between Day 0 to Day 7 to Day 14 [ Time Frame: See Primary Outcome Measure No. 2 ]See Primary Outcome Measure No. 2
- Change in urinary nitrite / nitrate levels from Day 0 to Day 14 [ Time Frame: Day 0 and Day 14 ]Nitrite/nitrate levels were assessed for correlation to the measures of intestinal permeability
- Change in anti-tTG levels from Screening to Day 21 [ Time Frame: Screening and Day 21 ]Changes between screening and Day 21 anti-tTG levels were assessed for correlation to the measures of intestinal permeability
- Change in cell markers and cytokines from PBMCs [ Time Frame: Days 0, 7, 14 and 21 ]Serum cytokine and cell surface marker determinations were assessed for correlation to the measures of intestinal permeability
- Changes in zonulin level [ Time Frame: Days 0, 7, 14 and 21 ]Serum zonulin levels were assessed for correlation to the measures of intestinal permeability

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.
- Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
- Must be on a gluten-free diet for at least the past 6 months.
Exclusion Criteria:
- Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
- Have diabetes (Type 1 or Type 2).
- Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
- Consuming oral corticosteroids or immune suppressants.

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): NCT00362856
United States, Arizona | |
Research Site | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
San Diego, California, United States, 92123 | |
United States, Massachusetts | |
Research Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Research Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Morristown, New Jersey, United States, 07960 | |
United States, North Dakota | |
Bismarck, North Dakota, United States, 58501 | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Virginia | |
Research Site | |
Richmond, Virginia, United States, 23298 |
Responsible Party: | 9 Meters Biopharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00362856 |
Other Study ID Numbers: |
CLIN1001-004 |
First Posted: | August 10, 2006 Key Record Dates |
Last Update Posted: | September 12, 2017 |
Last Verified: | September 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
larazotide acetate |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |