Clinical Trial Details

Trial ID: L0226
Source ID: NCT04880187
Associated Drug: AXA1125
Title: Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non Alcoholic Steatohepatitis (NASH)
Interventions: Drug: AXA1125|Drug: Placebo
Outcome Measures: Improvement in steatohepatitis|Resolution of NASH without worsening of fibrosis|Improvement of fibrosis by one stage without worsening of NASH|Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)|Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan???)|Change from baseline in hepatic fat as measured by MRI|Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Sponsor/Collaborators: Axcella Health, Inc
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 273
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: May 7, 2021
Completion Date: October 2023
Results First Posted: --
Last Update Posted: February 3, 2022
Locations: Adobe Clinical Research, LLC, Tucson, Arizona, 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|ClinCloud LLC, Maitland, Florida, United States|Panax Clinical Research, Miami Lakes, 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|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|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|Tandem Clinical Research GI, New York, New York, United States|Lucas Research - Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, United States|Innovative Clinical Research - Lafayette, 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|The Texas Liver Institute, 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|Impact Clinical Research, Waco, Texas, United States|EPIC Medical Research, Murray, Utah, United States|Manassas Clinical Research Center, Manassas, Virginia, United States|Virginia Commonwealth University Medical College of Virginia, Richmond, Virginia, United States|University of Calgary Liver Unit, Calgary, Alberta, Canada|LMC Diabetes & Endocrinology Ltd, London, Ontario, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|ID Clinic, Myslowice, CET, Poland|Fundacion de Investigacion (FDI), San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT04880187

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D021 AXA1125 Combinatory -- -- -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details