Clinical trial NCT04880187: Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Alcoholic Steatohepatitis (NASH)
Keywords: Steatosis
Lobular inflammation
Ballooning
Liver biopsy
Liver fat
Liver stiffness
NASH
Aminio Acids
Fibrosis
Lead sponsor: Axcella Health, Inc
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History or presence of liver disease (other than NAFLD or NASH)
* History or presence of cirrhosis and/or history or presence of hepatic decompensation

Primary outcomes:
measure: Improvement in steatohepatitis
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Resolution of NASH without worsening of fibrosis
timeFrame: Baseline to week 48
measure: Improvement of fibrosis by one stage without worsening of NASH
timeFrame: Baseline to week 48
measure: Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline to week 48
measure: Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
timeFrame: Baseline to week 48
measure: Change from baseline in hepatic fat as measured by MRI
timeFrame: Baseline to week 48
measure: Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
timeFrame: Baseline to week 48
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Gardena
country: United States
facility: National Research Institute
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research , Inc.
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland Groover Clinical Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud LLC
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Miami
country: United States
facility: La Salud Research
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Pinellas Park
country: United States
facility: Theia Clinical Research, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Viera
country: United States
facility: ClinCloud, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Hammond
country: United States
facility: ASHA Clinical Research
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University (IU) School of Medicine
state: Indiana
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Tandem Clinical Research GI
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Biloxi
country: United States
facility: The National Diabetes & Obesity Research Institute
state: Mississippi
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Tandem Clinical Research GI
state: New York
city: Morehead City
country: United States
facility: Lucas Research - Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: American Research Corporation
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Red Oak
country: United States
facility: EPIC Medical Research
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Stafford
country: United States
facility: R & H Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research, LLC
state: Texas
city: Waco
country: United States
facility: Impact Clinical Research
state: Texas
city: Riverton
country: United States
facility: Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical College of Virginia
state: Virginia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Calgary
country: Canada
facility: University of Calgary Liver Unit
state: Alberta
city: London
country: Canada
facility: LMC Diabetes & Endocrinology Ltd
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
city: La Tronche
country: France
facility: CHU Grenoble-Alpes - Hopital Michallon
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - HCL
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint Eloi
city: Paris
country: France
facility: AP-HP Hopital Saint Antoine
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut-Leveque
city: Villejuif
country: France
facility: AP-HP Hopital Paul Brousse
city: Myslowice
country: Poland
facility: ID Clinic
state: CET
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion (FDI)
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Pinnacle Clinical Research
name: Stephen Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References: