MedPath

Larazotide

Generic Name
Larazotide
Drug Type
Small Molecule
Chemical Formula
C32H55N9O10
CAS Number
258818-34-7
Unique Ingredient Identifier
ZN3R5560ZV
Background

An octapeptide inhibitor of paracellular permeability whose structure is derived from a protein (zonula occludens toxin) secreted by Vibrio cholerae for treatment of Coeliac disease.

Indication

Investigated for use/treatment in autoimmune diseases, diabetes mellitus type 1, and gastrointestinal diseases and disorders (miscellaneous).

AT1001 for the Treatment of Long COVID

Phase 2
Recruiting
Conditions
Post Acute Sequelae of COVID-19
Long COVID
Long COVID-19
Post Acute COVID-19 Syndrome
Interventions
First Posted Date
2023-02-28
Last Posted Date
2025-01-23
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
48
Registration Number
NCT05747534
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

AT1001 for the Treatment of COVID-19 Related MIS-C

Phase 2
Terminated
Conditions
Covid19
Multisystem Inflammatory Syndrome in Children
Interventions
First Posted Date
2021-08-26
Last Posted Date
2024-06-13
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
12
Registration Number
NCT05022303
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

Phase 3
Terminated
Conditions
Celiac Disease
Interventions
Drug: Matching Placebo
First Posted Date
2018-06-26
Last Posted Date
2022-07-26
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
307
Registration Number
NCT03569007
Locations
🇺🇸

Research Site, Wauwatosa, Wisconsin, United States

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Phase 2
Completed
Conditions
Celiac Disease
Interventions
First Posted Date
2011-07-18
Last Posted Date
2017-09-20
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
342
Registration Number
NCT01396213

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Phase 2
Completed
Conditions
Celiac Disease
Interventions
Drug: Placebo
Dietary Supplement: Gluten 900 mg
First Posted Date
2009-04-29
Last Posted Date
2017-09-20
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
42
Registration Number
NCT00889473
Locations
🇨🇦

Study Site, Edmonton, Alberta, Canada

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

Phase 2
Completed
Conditions
Celiac Disease
Interventions
First Posted Date
2008-02-21
Last Posted Date
2017-09-20
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
105
Registration Number
NCT00620451
Locations
🇪🇸

Study Site, Valladolid, Spain

🇪🇸

Study site, Madrid, Spain

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

Phase 2
Completed
Conditions
Celiac Disease
Interventions
Drug: placebo
Dietary Supplement: 900 mg gluten
First Posted Date
2007-06-27
Last Posted Date
2017-09-20
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
171
Registration Number
NCT00492960
Locations
🇨🇦

Study Site, Winnipeg, Canada

Safety of Larazotide Acetate in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2006-10-11
Last Posted Date
2017-09-12
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
24
Registration Number
NCT00386490
Locations
🇺🇸

Parexel, Baltimore, Maryland, United States

Safety Study of Larazotide Acetate to Treat Celiac Disease.

Phase 1
Completed
Conditions
Celiac Disease
Interventions
First Posted Date
2006-10-11
Last Posted Date
2017-09-11
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
21
Registration Number
NCT00386165
Locations
🇺🇸

Parexel, Baltimore, Maryland, United States

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Phase 2
Completed
Conditions
Celiac Disease
Interventions
First Posted Date
2006-08-10
Last Posted Date
2017-09-12
Lead Sponsor
9 Meters Biopharma, Inc.
Target Recruit Count
80
Registration Number
NCT00362856
Locations
🇺🇸

Research Site, Richmond, Virginia, United States

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