Does Larazotide acetate work?
Partly: some human trials, with gaps: four trials in 626 patients, then a big trial stopped early.
Larazotide was tested in four randomized placebo-controlled trials in celiac disease with 626 patients in total, pooled in a 2021 meta-analysis, and in a phase 3 trial planned for 525 patients that was stopped at the halfway point. Human controlled data exist, which keeps it at B, but symptom benefit appeared only during deliberate gluten challenge, the permeability measure did not change, and the program ended. 23
A 2021 systematic review and meta-analysis pooled four randomized placebo-controlled trials of larazotide in celiac disease. They covered 626 patients. Some patients got a daily gluten challenge. In them, larazotide improved gut symptom scores. It also cut gluten-related diarrhoea compared with placebo. In patients on a gluten-free diet, there was no difference. Across all trials, the lactulose-to-mannitol ratio did not differ from placebo. This ratio measures gut leakiness (intestinal permeability). The drug was designed to change it. 3
The phase 3 trial was called CedLara. It enrolled adults with celiac disease who still had symptoms on a gluten-free diet. It compared two larazotide doses with placebo over 12 weeks. In June 2022, an interim analysis covered about half of the 525 planned patients. It found that proving a difference would take too many more patients. That was too many to justify going on. The sponsor closed the trial. 2
Evidence checklist
- Randomised controlled trial Several placebo-controlled celiac trials
- Human study over 100 people Phase 3 planned for 525, stopped midway
- More than one research group One developer line across sponsors
- Clinical outcomes, not surrogate markers Symptom scores; permeability did not improve
- Human safety data beyond case reports Adverse events similar to placebo
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Citations
- Slifer 2021, Am J Physiol GI: larazotide acetate, a pharmacological peptide approach to tight junction regulation doi.org
- Beyond Celiac 2022: Phase 3 study of larazotide acetate discontinued beyondceliac.org
- Hoilat 2022, Clin Res Hepatol Gastroenterol: larazotide acetate for celiac disease, systematic review and meta-analysis of four RCTs doi.org
Reference information only, not medical advice. Drawn from the Larazotide acetate article, fact-checked against the cited sources. No dosing anywhere on this site.