Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)
1 other identifier
interventional
273
7 countries
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedSeptember 8, 2022
May 1, 2022
2.3 years
May 3, 2021
September 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in steatohepatitis
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
Baseline to Week 48
Secondary Outcomes (6)
Resolution of NASH without worsening of fibrosis
Baseline to week 48
Improvement of fibrosis by one stage without worsening of NASH
Baseline to week 48
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
- +1 more secondary outcomes
Study Arms (3)
AXA1125 22.6g
EXPERIMENTAL22.6 g AXA1125 administered orally BID with or without food
AXA1125 33.9g
EXPERIMENTAL33.9 g AXA1125 administered orally BID with or without food
Placebo
PLACEBO COMPARATORMatching Placebo administered orally BID with or without food
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
San Fernando Valley Health Institute
Canoga Park, California, 91304, United States
National Research Institute
Gardena, California, 90247, United States
National Research Institute
Huntington Park, California, 90255, United States
OM Research LLC
Lancaster, California, 93534, United States
National Research Institute
Los Angeles, California, 90057, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Precision Research Institute, LLC
San Diego, California, 92114, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434, United States
Synergy Healthcare
Bradenton, Florida, 34208, United States
Tampa Bay Medical Research , Inc.
Clearwater, Florida, 33761, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256, United States
ClinCloud LLC
Maitland, Florida, 32751, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616, United States
La Salud Research
Miami, Florida, 33155, United States
Genoma Research Group, Inc
Miami, Florida, 33173, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Theia Clinical Research, LLC
Pinellas Park, Florida, 33709, United States
Progressive Medical Research
Port Orange, Florida, 32124, United States
ClinCloud, LLC
Viera, Florida, 32940, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Conquest Research
Winter Park, Florida, 32789, United States
ASHA Clinical Research
Hammond, Indiana, 46324, United States
Indiana University (IU) School of Medicine
Indianapolis, Indiana, 46202, United States
Delta Research Partners
Bastrop, Louisiana, 71201, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Tandem Clinical Research GI
Metairie, Louisiana, 70006, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
The National Diabetes & Obesity Research Institute
Biloxi, Mississippi, 39532, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Tandem Clinical Research GI
New York, New York, 10033, United States
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
American Research Corporation
Austin, Texas, 78757, United States
Pinnacle Clinical Research
Austin, Texas, 78757, United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099, United States
R & H Clinical Research
Katy, Texas, 77494, United States
EPIC Medical Research
Red Oak, Texas, 75154, United States
American Research Corporation
San Antonio, Texas, 78215, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
R & H Clinical Research
Stafford, Texas, 77477, United States
Simcare Medical Research, LLC
Sugar Land, Texas, 77478, United States
Impact Clinical Research
Waco, Texas, 76710, United States
Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
Riverton, Utah, 84065, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, 23298, 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, M6H 3M1, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Harrison, MD
Pinnacle Clinical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 10, 2021
Study Start
May 7, 2021
Primary Completion
September 1, 2023
Study Completion
October 1, 2023
Last Updated
September 8, 2022
Record last verified: 2022-05