NCT00362856 is a Phase 2 clinical trial of larazotide acetate in Celiac Disease, sponsored by 9 Meters Biopharma, Inc..

Who is sponsoring NCT00362856?

NCT00362856 is sponsored by 9 Meters Biopharma, Inc..

What drugs are being tested in NCT00362856?

Interventions in NCT00362856: larazotide acetate, Placebo.

What condition does NCT00362856 study?

NCT00362856 studies Celiac Disease.

Is NCT00362856 still recruiting?

NCT00362856 is currently completed. Last updated 12 September 2017.

Last reviewed 2017-09-12 · How we verify

NCT00362856

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Completed Phase 2 Last updated 12 September 2017

What this trial tests

Phase 2 trial testing larazotide acetate in Celiac Disease in 80 participants. Completed in 6 March 2007.

Timeline

13 September 2006

Primary endpoint
6 March 2007

6 March 2007

Quick facts

Lead sponsor	9 Meters Biopharma, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	13 September 2006
Primary completion	6 March 2007
Estimated completion	6 March 2007
Sites	9 locations across United States

Drugs / interventions tested

larazotide acetate — full drug profile →
Placebo

Conditions studied

Celiac Disease — all drugs for Celiac Disease →

Sponsor

9 Meters Biopharma, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.
Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, et al · · 2012 · cited 128× · PMID 22825365 · DOI 10.1038/ajg.2012.211
Evolving Therapy for Celiac Disease.
Yoosuf S, Makharia GK. · · 2019 · cited 54× · PMID 31157194 · DOI 10.3389/fped.2019.00193
Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions.
Veres-Székely A, Szász C, Pap D, Szebeni B, et al · · 2023 · cited 53× · PMID 37108711 · DOI 10.3390/ijms24087548
Novel Nondietary Therapies for Celiac Disease.
Alhassan E, Yadav A, Kelly CP, Mukherjee R. · · 2019 · cited 37× · PMID 31146067 · DOI 10.1016/j.jcmgh.2019.04.017
Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials.
Gottlieb K, Dawson J, Hussain F, Murray JA. · · 2015 · cited 26× · PMID 25725041 · DOI 10.1093/gastro/gov006
Gliadin Sequestration as a Novel Therapy for Celiac Disease: A Prospective Application for Polyphenols.
Van Buiten CB, Elias RJ. · · 2021 · cited 14× · PMID 33435615 · DOI 10.3390/ijms22020595
Celiac Disease and Non-celiac Wheat Sensitivity: State of Art of Non-dietary Therapies.
Serena G, D'Avino P, Fasano A. · · 2020 · cited 13× · PMID 33015123 · DOI 10.3389/fnut.2020.00152
Beyond the gluten-free diet: Innovations in celiac disease therapeutics.
Massironi S, Franchina M, Elvevi A, Barisani D. · · 2024 · cited 9× · PMID 39493330 · DOI 10.3748/wjg.v30.i38.4194

Verify or expand the search:

Other trials of larazotide acetate

Trials testing the same drug.

NCT00386490 — Safety of Larazotide Acetate in Healthy Volunteers · Phase 1 · completed
NCT00386165 — Safety Study of Larazotide Acetate to Treat Celiac Disease. · Phase 1 · completed

Other recruiting trials for Celiac Disease

Currently open trials in the same condition.

NCT07239336 — Study of DONQ52 in Active Celiac Disease · Phase 2 · recruiting
NCT07585669 — Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease · NA · recruiting
NCT07063823 — A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease · Phase 1 · recruiting
NCT06982963 — Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease · Phase 2 · recruiting
NCT07177287 — The Effect of a Navigator Nurse- Supported Mobile Application Developed Based on the IMB Model on the Quality of Life of · NA · recruiting

Other 9 Meters Biopharma, Inc. trials

Trials by the same sponsor.

NCT04988997 — VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome. · Phase 2 · terminated
NCT04379856 — Proof of Concept Study in Patients With Short Bowel Syndrome · Phase 1, PHASE2 · unknown
NCT03569007 — Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms · Phase 3 · terminated
NCT01396213 — A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease · Phase 2 · completed
NCT00386490 — Safety of Larazotide Acetate in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00362856 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by 9 Meters Biopharma, Inc.
Last refreshed: 12 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00362856.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing