A Phase 2 interventional study of larazotide acetate and placebo in Celiac Disease, sponsored by 9 Meters Biopharma, Inc.. Completed at 23 sites in 2 countries. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by 9 Meters Biopharma, Inc. · Phase 2, Interventional, and Treatment
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.
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 171 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →9 Meters Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: larazotide acetate · Dietary Supplement: 900 mg gluten
larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: larazotide acetate · Dietary Supplement: 900 mg gluten
larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: larazotide acetate · Dietary Supplement: 900 mg gluten
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: placebo · Dietary Supplement: 900 mg gluten
gelatin capsules
Also known as: AT-1001, INN-202
gelatin capsules
gelatin capsules
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
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.
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
Time frame: Up to 6 weeks
To prospectively validate a composite, weighted index of celiac disease activity
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire
Time frame: GSRS was completed weekly throughout the study.
Plan to share: No
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
9 Meters Biopharma, Inc.