What the studies show
The higher doses were flat. Where a drug's effect does not increase with dose, the most parsimonious explanation for a single positive arm is chance.
“The 1- and 2-mg doses were no different than placebo for any end point.”
A few small or poorly-controlled human studies. Enough to be interesting; not enough to count on. Most of what gets called “clinically proven” online lives here.
- 1Leffler DA, Kelly CP, Green PH, et al. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.Gastroenterology, 2015;148:1311–1319342 randomised; 12 weeks; three doses versus placebo. Primary endpoint met at the lowest dose only.
In context
Larazotide is a synthetic eight-amino-acid peptide taken by mouth to tighten the junctions between intestinal cells, developed as the first drug for persistent symptoms in coeliac disease despite a gluten-free diet. Its 342-person phase 2b trial met its primary endpoint at the lowest of three doses while the two higher doses did no better than placebo. The phase 3 trial, CeDLara, was stopped in 2022 after an interim analysis showed it was unlikely to succeed. It is not approved anywhere.
Larazotide is investigational (phase 3 discontinued). Legal status differs by country — see the regulation section or the jurisdiction pages.
Questions
Is Larazotide proven to help with dose–response?
What studies are behind the grade?
Is Larazotide approved for this?
Other outcomes for Larazotide
- CCoeliac symptoms on a gluten-free diet1 phase 2b RCT (n=342, 12 wk)
- AConfirmation in phase 31 phase 3 RCT stopped at interim analysis
- CSafetyadversePhase 2 programme
Written and maintained by LYO Research — how pages are written and checked. Reviewed 29 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →