Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
NCT ID: NCT04880187
Last Updated: 2022-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
273 participants
INTERVENTIONAL
2021-05-07
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AXA1125 22.6g
22.6 g AXA1125 administered orally BID with or without food
AXA1125
AXA1125 administered BID with or without food
AXA1125 33.9g
33.9 g AXA1125 administered orally BID with or without food
AXA1125
AXA1125 administered BID with or without food
Placebo
Matching Placebo administered orally BID with or without food
Placebo
Matching Placebo administered BID with or without food
Interventions
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AXA1125
AXA1125 administered BID with or without food
Placebo
Matching Placebo administered BID with or without food
Eligibility Criteria
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Inclusion Criteria
* Male and female adults aged \> 18 years.
* Must have NASH and fibrosis on a liver biopsy sample
* If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
* Subjects may have a diagnosis of T2DM
Exclusion Criteria
* History or presence of cirrhosis and/or history or presence of hepatic decompensation
18 Years
ALL
No
Sponsors
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Axcella Health, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Harrison, MD
Role: PRINCIPAL_INVESTIGATOR
Pinnacle Clinical Research
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
National Research Institute
Gardena, California, United States
National Research Institute
Huntington Park, California, United States
OM Research LLC
Lancaster, California, United States
National Research Institute
Los Angeles, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Precision Research Institute, LLC
San Diego, California, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Synergy Healthcare
Bradenton, Florida, United States
Tampa Bay Medical Research , Inc.
Clearwater, Florida, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, United States
ClinCloud LLC
Maitland, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
La Salud Research
Miami, Florida, United States
Genoma Research Group, Inc
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Theia Clinical Research, LLC
Pinellas Park, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
ClinCloud, LLC
Viera, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
ASHA Clinical Research
Hammond, Indiana, United States
Indiana University (IU) School of Medicine
Indianapolis, Indiana, United States
Delta Research Partners
Bastrop, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Tandem Clinical Research GI
Metairie, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
The National Diabetes & Obesity Research Institute
Biloxi, Mississippi, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Tandem Clinical Research GI
New York, New York, United States
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
American Research Corporation
Austin, Texas, United States
Pinnacle Clinical Research
Austin, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
R & H Clinical Research
Katy, Texas, United States
EPIC Medical Research
Red Oak, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
R & H Clinical Research
Stafford, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Impact Clinical Research
Waco, Texas, United States
Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
Riverton, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, United States
Flinders Medical Centre
Bedford Park, , Australia
Royal Brisbane and Women's Hospital
Brisbane, , Australia
Monash Medical Centre
Clayton, , Australia
Concord Repatriation General Hospital
Concord, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
University of Calgary Liver Unit
Calgary, Alberta, Canada
LMC Diabetes & Endocrinology Ltd
London, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Nova Scotia Health Authority
Halifax, , Canada
CHU Grenoble-Alpes - Hopital Michallon
La Tronche, , France
Hôpital de la Croix Rousse - HCL
Lyon, , France
CHU de Montpellier - Hopital Saint Eloi
Montpellier, , France
AP-HP Hopital Saint Antoine
Paris, , France
CHU Bordeaux - Hopital Haut-Leveque
Pessac, , France
AP-HP Hopital Paul Brousse
Villejuif, , France
ID Clinic
Mysłowice, CET, Poland
Fundacion de Investigacion (FDI)
San Juan, , Puerto Rico
King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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AXA1125-101
Identifier Type: -
Identifier Source: org_study_id
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