Completed PHASE2 INTERVENTIONAL 4-arm NCT00492960

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge

Sponsor: 9 Meters Biopharma, Inc.

Conditions Celiac Disease

Interventions 900 mg gluten larazotide acetate placebo

Updated 9 times since 2017 Last updated: Sep 15, 2017 Started: Aug 31, 2007 Primary completion: Oct 31, 2008 Completion: Mar 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Celiac Disease and is currently completed. 9 Meters Biopharma, Inc. leads this study, which shows 9 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE2
Jan 2021 — Apr 2022 [monthly]

Completed PHASE2
Aug 2020 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 4 earlier versions

Jun 2018 — Aug 2020 [monthly]

Completed PHASE2
Oct 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Oct 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Aug 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

9 Meters Biopharma, Inc.

Data source: 9 Meters Biopharma, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Asheville, United States , Boston, United States , Calgary, Canada , Chicago, United States , Cleveland, United States , Colorado Springs, United States , Edmonton, Canada , Hagerstown, United States , Houston, United States , Kelowna, Canada and 13 more locations