A randomized, double-blind, placebo-controlled trial has assessed the efficacy of larazotide acetate in controlling symptoms of coeliac disease. 342 patients with coeliac disease were treated with either placebo, 0.5, 1.0 or 2.0 mg larazotide acetate for 12 weeks in addition to maintaining their gluten-free diet. The 0.5 mg dose was more effective than placebo at reducing symptoms; safety was comparable to that of the placebo group. The higher doses of larazotide acetate were no better than placebo.