Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Phase 2 Completed 80 enrolled 9 Meters Biopharma, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

Timeline

Start: 2006-09-13
Primary completion: 2007-03-06
Completion: 2007-03-06

Outcome

Missed primary endpoint

paper Among patients receiving the gluten challenge, the difference in the LAMA ratios for the larazotide acetate and placebo groups was not statistically significant. PMID 22825365 ↗

Publications

Results Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol. 2012 Oct;107(10):1554-62. doi: 10.1038/ajg.2012.211. Epub 2012 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Larazotide	Peptide	0.25 mg	Oral
Subject	Larazotide	Peptide	1 mg	Oral
Subject	Larazotide	Peptide	4 mg	Oral
Subject	Larazotide	Peptide	8 mg	Oral