Claimed effect · Larazotide

Does Larazotide help with confirmation in phase 3?

A
Grade A — established in humans1 phase 3 RCT stopped at interim analysis · effect size: not measurable
Short answerEstablished in humans. 1 phase 3 RCT stopped at interim analysis point the same way: no measurable effect, or none yet shown. CeDLara, the registrational phase 3 trial, was discontinued in June 2022 after a pre-specified interim analysis of roughly half of a planned 525 patients: the sponsor said the number of additional patients needed to show an effect was too large to support continuing. A futility stop is a negative result, and graded on the strength of the design rather than the direction of the finding.

What the studies show

CeDLara, the registrational phase 3 trial, was discontinued in June 2022 after a pre-specified interim analysis of roughly half of a planned 525 patients: the sponsor said the number of additional patients needed to show an effect was too large to support continuing. A futility stop is a negative result, and graded on the strength of the design rather than the direction of the finding.

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

  1. 1
    9 Meters Biopharma. Discontinuation of the phase 3 CeDLara trial of larazotide in celiac disease following interim analysis.Press release, 21 Jun 2022 (SEC exhibit 99.1)Interim analysis covered about half of a planned 525 patients; the release says the number of additional patients needed was too large to support trial continuation. NCT03569007.

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 confirmation in phase 3?
Yes, as far as human trials can show it: 1 phase 3 RCT stopped at interim analysis. LYO grades this outcome A.
What studies are behind the grade?
CeDLara, the registrational phase 3 trial, was discontinued in June 2022 after a pre-specified interim analysis of roughly half of a planned 525 patients: the sponsor said the number of additional patients needed to show an effect was too large to support continuing. A futility stop is a negative result, and graded on the strength of the design rather than the direction of the finding.
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 →