Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
- Registration Number
- NCT04880187
- Lead Sponsor
- Axcella Health, Inc
- Brief Summary
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 273
- Willing to participate in the study and provide written informed consent.
- 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
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AXA1125 22.6g AXA1125 22.6 g AXA1125 administered orally BID with or without food AXA1125 33.9g AXA1125 33.9 g AXA1125 administered orally BID with or without food Placebo Placebo Matching Placebo administered orally BID with or without food
- Primary Outcome Measures
Name Time Method Improvement in steatohepatitis Baseline to Week 48 2-point improvement from baseline to Week 48 in the non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) based on a scale from 0-8 with 0 being no NASH and 8 being the highest score
- Secondary Outcome Measures
Name Time Method Resolution of NASH without worsening of fibrosis Baseline to week 48 The proportion of subjects with resolution of NASH with no worsening of fibrosis defined as a post-treatment ballooning score of 0 and an inflammation score of 0 or 1 on liver biopsy.
Improvement of fibrosis by one stage without worsening of NASH Baseline to week 48 The proportion of subjects who have at least a 1-stage improvement in fibrosis and no worsening of NASH based on liver biopsy 0 being no fibrosis and 4 being the worse.
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs) Baseline to week 48 Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™) Baseline to week 48 Change from baseline in hepatic fat as measured by MRI Baseline to week 48 Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c) Baseline to week 48
Trial Locations
- Locations (69)
National Research Institute
🇺🇸Los Angeles, California, United States
Synergy Healthcare
🇺🇸Bradenton, Florida, United States
Tampa Bay Medical Research , Inc.
🇺🇸Clearwater, Florida, United States
ClinSearch LLC
🇺🇸Chattanooga, Tennessee, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
La Salud Research
🇺🇸Miami, Florida, United States
Indiana University (IU) School of Medicine
🇺🇸Indianapolis, Indiana, United States
Pioneer Research Solutions Inc.
🇺🇸Houston, Texas, United States
Jubilee Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
OM Research LLC
🇺🇸Lancaster, California, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
San Fernando Valley Health Institute
🇺🇸Canoga Park, California, United States
Precision Research Institute, LLC
🇺🇸San Diego, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
ENCORE Borland Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
Theia Clinical Research, LLC
🇺🇸Pinellas Park, Florida, United States
Genoma Research Group, Inc
🇺🇸Miami, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Fundacion de Investigacion (FDI)
🇵🇷San Juan, Puerto Rico
ID Clinic
🇵🇱Myslowice, CET, Poland
Lucas Research - Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
ClinCloud, LLC
🇺🇸Viera, Florida, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
American Research Corporation
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research
🇺🇸San Antonio, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Nova Scotia Health Authority
🇨🇦Halifax, Canada
Evolution Clinical Trials, Inc.
🇺🇸Hialeah Gardens, Florida, United States
Tandem Clinical Research GI
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Impact Clinical Research
🇺🇸Waco, Texas, United States
Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
🇺🇸Riverton, Utah, United States
Virginia Commonwealth University Medical College of Virginia
🇺🇸Richmond, Virginia, United States
Monash Medical Centre
🇦🇺Clayton, Australia
Concord Repatriation General Hospital
🇦🇺Concord, Australia
University of Calgary Liver Unit
🇨🇦Calgary, Alberta, 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
CHU Bordeaux - Hopital Haut-Leveque
🇫🇷Pessac, France
AP-HP Hopital Paul Brousse
🇫🇷Villejuif, France
Rapid City Medical Center
🇺🇸Rapid City, South Dakota, United States
Excel Medical Clinical Trials, LLC
🇺🇸Boca Raton, Florida, United States
The National Diabetes & Obesity Research Institute
🇺🇸Biloxi, Mississippi, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Delta Research Partners
🇺🇸Bastrop, Louisiana, United States
ClinCloud LLC
🇺🇸Maitland, Florida, United States
ASHA Clinical Research
🇺🇸Hammond, Indiana, United States
R & H Clinical Research
🇺🇸Stafford, Texas, United States
AP-HP Hopital Saint Antoine
🇫🇷Paris, France
EPIC Medical Research
🇺🇸Red Oak, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Flinders Medical Centre
🇦🇺Bedford Park, Australia
King's College Hospital
🇬🇧London, United Kingdom
LMC Diabetes & Endocrinology Ltd
🇨🇦London, Ontario, Canada
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Australia