Claimed effect · Larazotide

Does Larazotide help with coeliac symptoms on a gluten-free diet?

C
Grade C — weak human evidence1 phase 2b RCT (n=342, 12 wk) · effect size: small
Short answerWeak human evidence. 1 phase 2b RCT (n=342, 12 wk): enough to be interesting, not enough to count on. Where an effect is seen it is a small effect. In a 12-week trial of 342 adults with coeliac disease and persistent symptoms despite a gluten-free diet, the lowest of three doses reduced symptoms against placebo on the primary endpoint. The two higher doses did not. An unexplained inverse dose–response in a single phase 2b is weak ground, and the confirmatory trial did not confirm it.

What the studies show

In a 12-week trial of 342 adults with coeliac disease and persistent symptoms despite a gluten-free diet, the lowest of three doses reduced symptoms against placebo on the primary endpoint. The two higher doses did not. An unexplained inverse dose–response in a single phase 2b is weak ground, and the confirmatory trial did not confirm it.

“The primary end point was met with the 0.5-mg dose of larazotide acetate, with fewer symptoms compared with placebo by modified intention to treat (n = 340) (analysis of covariance, P = .022; mixed model for repeated measures, P = .005).”

Verbatim, from the abstractLeffler 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;148:1311–1319

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.

  1. 1
    Leffler 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 coeliac symptoms on a gluten-free diet?
No. The human evidence is weak (1 phase 2b RCT (n=342, 12 wk)); LYO grades it C.
What studies are behind the grade?
In a 12-week trial of 342 adults with coeliac disease and persistent symptoms despite a gluten-free diet, the lowest of three doses reduced symptoms against placebo on the primary endpoint. The two higher doses did not. An unexplained inverse dose–response in a single phase 2b is weak ground, and the confirmatory trial did not confirm it.
Is Larazotide approved for this?
No. Larazotide is investigational (phase 3 discontinued); it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for Larazotide

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 →