NCT00386165 is a Phase 1 clinical trial of larazotide acetate in Celiac Disease, sponsored by 9 Meters Biopharma, Inc..

Who is sponsoring NCT00386165?

NCT00386165 is sponsored by 9 Meters Biopharma, Inc..

What drugs are being tested in NCT00386165?

Interventions in NCT00386165: larazotide acetate.

What condition does NCT00386165 study?

NCT00386165 studies Celiac Disease.

Is NCT00386165 still recruiting?

NCT00386165 is currently completed. Last updated 11 September 2017.

Last reviewed 2017-09-11 · How we verify

NCT00386165

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

Safety Study of Larazotide Acetate to Treat Celiac Disease.

Completed Phase 1 Last updated 11 September 2017

What this trial tests

Phase 1 trial testing larazotide acetate in Celiac Disease in 21 participants. Completed in 26 January 2006.

Timeline

29 November 2005

Primary endpoint
26 January 2006

26 January 2006

Quick facts

Lead sponsor	9 Meters Biopharma, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	21
Start date	29 November 2005
Primary completion	26 January 2006
Estimated completion	26 January 2006
Sites	1 location across United States

Drugs / interventions tested

larazotide acetate — full drug profile →

Conditions studied

Celiac Disease — all drugs for Celiac Disease →

Sponsor

9 Meters Biopharma, Inc. — full company profile →

Who can join

Adults 18 to 59, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

Publications & conference data

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

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
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
Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
Girbal-González M, Pérez-Cano FJ. · · 2025 · cited 2× · PMID 41010485 · DOI 10.3390/nu17182960
From an understanding of etiopathogenesis to novel therapies-what is new in the treatment of celiac disease?
Skoracka K, Hryhorowicz S, Tovoli F, Raiteri A, et al · · 2024 · cited 2× · PMID 38698821 · DOI 10.3389/fphar.2024.1378172

Verify or expand the search:

Other trials of larazotide acetate

Trials testing the same drug.

NCT00362856 — Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects · Phase 2 · completed
NCT00386490 — Safety of Larazotide Acetate in Healthy Volunteers · 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
NCT00362856 — Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects · Phase 2 · 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 NCT00386165 (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: 11 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/NCT00386165.

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