Recruiting

Phase 2

AXA1125Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Sponsor:

Axcella Health, Inc

Code:

NCT04880187

Conditions

Non Alcoholic Steatohepatitis (NASH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AXA1125

Placebo

Study Details

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.

Conditions

Non Alcoholic Steatohepatitis (NASH)

Study ID

NCT04880187

Start date

May 7, 2021

Status verified date

May, 2022

Completion date

Oct, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

273 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AXA1125 22.6g

22.6 g AXA1125 administered orally BID with or without food

experimental: AXA1125 33.9g

33.9 g AXA1125 administered orally BID with or without food

placebo comparator: Placebo

Matching Placebo administered orally BID with or without food

Interventions

AXA1125

AXA1125 administered BID with or without food

Placebo

Matching Placebo administered BID with or without food

Primary outcome measure

Improvement in steatohepatitis [ Time Frame: Baseline to Week 48 ]

Central Contacts and Locations

Central contacts

Margaret Koziel, MD

(857) 320-3200 clinicaltrials@axcellahealth.com

Locations

Cullman Clinical Trials

Recruiting

Cullman, Alabama, United States, 35055

Adobe Clinical Research, LLC

Recruiting

Tucson, Arizona, United States, 85712

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

San Fernando Valley Health Institute

Recruiting

Canoga Park, California, United States, 91304

National Research Institute

Recruiting

Gardena, California, United States, 90247

National Research Institute

Recruiting

Huntington Park, California, United States, 90255

OM Research LLC

Recruiting

Lancaster, California, United States, 93534

National Research Institute

Recruiting

Los Angeles, California, United States, 90057

Inland Empire Liver Foundation

Recruiting

Rialto, California, United States, 92377

Precision Research Institute, LLC

Recruiting

San Diego, California, United States, 92114

Excel Medical Clinical Trials, LLC

Recruiting

Boca Raton, Florida, United States, 33434

Synergy Healthcare

Recruiting

Bradenton, Florida, United States, 34208

Tampa Bay Medical Research , Inc.

Recruiting

Clearwater, Florida, United States, 33761

Evolution Clinical Trials, Inc.

Recruiting

Hialeah Gardens, Florida, United States, 33016

Westside Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32205

ENCORE Borland Groover Clinical Research

Recruiting

Jacksonville, Florida, United States, 32256

ClinCloud LLC

Recruiting

Maitland, Florida, United States, 32751

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Clinical Pharmacology of Miami, LLC

Recruiting

Miami, Florida, United States, 33014-3616

La Salud Research

Recruiting

Miami, Florida, United States, 33155

Genoma Research Group, Inc

Recruiting

Miami, Florida, United States, 33173

Sensible Healthcare, LLC

Recruiting

Ocoee, Florida, United States, 34761

Theia Clinical Research, LLC

Recruiting

Pinellas Park, Florida, United States, 33709

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32124

ClinCloud, LLC

Recruiting

Viera, Florida, United States, 32940

Metabolic Research Institute, Inc.

Recruiting

West Palm Beach, Florida, United States, 33401

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

ASHA Clinical Research

Recruiting

Hammond, Indiana, United States, 46324

Indiana University (IU) School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Delta Research Partners

Recruiting

Bastrop, Louisiana, United States, 71201

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Tandem Clinical Research GI

Recruiting

Metairie, Louisiana, United States, 70006

Louisiana Research Center, LLC

Recruiting

Shreveport, Louisiana, United States, 71105

The National Diabetes & Obesity Research Institute

Recruiting

Biloxi, Mississippi, United States, 39532

Jubilee Clinical Research, Inc.

Recruiting

Las Vegas, Nevada, United States, 89106

Sierra Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89106

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Tandem Clinical Research GI

Recruiting

New York, New York, United States, 10033

Lucas Research - Diabetes & Endocrinology Consultants, PC

Recruiting

Morehead City, North Carolina, United States, 28557

Consultants for Clinical Research

Recruiting

Cincinnati, Ohio, United States, 45219

Rapid City Medical Center

Recruiting

Rapid City, South Dakota, United States, 57701

ClinSearch LLC

Recruiting

Chattanooga, Tennessee, United States, 37421

Texas Clinical Research Institute

Recruiting

Arlington, Texas, United States, 76012

American Research Corporation

Recruiting

Austin, Texas, United States, 78757

Pinnacle Clinical Research

Recruiting

Austin, Texas, United States, 78757

Pioneer Research Solutions Inc.

Recruiting

Houston, Texas, United States, 77099

R & H Clinical Research

Recruiting

Katy, Texas, United States, 77494

EPIC Medical Research

Recruiting

Red Oak, Texas, United States, 75154

American Research Corporation

Recruiting

San Antonio, Texas, United States, 78215

Endeavor Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

Pinnacle Clinical Research

Recruiting

San Antonio, Texas, United States, 78229

R & H Clinical Research

Recruiting

Stafford, Texas, United States, 77477

Simcare Medical Research, LLC

Recruiting

Sugar Land, Texas, United States, 77478

Impact Clinical Research

Recruiting

Waco, Texas, United States, 76710

Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog

Recruiting

Riverton, Utah, United States, 84065

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

Virginia Commonwealth University Medical College of Virginia

Recruiting

Richmond, Virginia, United States, 23298

University of Calgary Liver Unit

Recruiting

Calgary, Alberta, Canada

LMC Diabetes & Endocrinology Ltd

Recruiting

London, Ontario, Canada

Toronto Liver Centre

Recruiting

Toronto, Ontario, Canada, M6H 3M1

Nova Scotia Health Authority

Recruiting

Halifax, Canada

More Information

Sponsor

Axcella Health, Inc

Last update posted

Sep 8, 2022

Last verified

May, 2022

Keywords

Steatosis
Lobular inflammation
Ballooning
Liver biopsy
Liver fat
Liver stiffness
NASH
Aminio Acids
Fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Axcella Health, Inc on 2022-09-08.