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

Primary Purpose

Non Alcoholic Steatohepatitis (NASH)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AXA1125
Placebo
Sponsored by
Axcella Health, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis (NASH) focused on measuring Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids, Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cullman Clinical TrialsRecruiting
  • Adobe Clinical Research, LLCRecruiting
  • Del Sol Research Management, LLCRecruiting
  • San Fernando Valley Health InstituteRecruiting
  • National Research InstituteRecruiting
  • National Research InstituteRecruiting
  • OM Research LLCRecruiting
  • National Research InstituteRecruiting
  • Inland Empire Liver FoundationRecruiting
  • Precision Research Institute, LLCRecruiting
  • Excel Medical Clinical Trials, LLCRecruiting
  • Synergy HealthcareRecruiting
  • Tampa Bay Medical Research , Inc.Recruiting
  • Evolution Clinical Trials, Inc.Recruiting
  • Westside Center for Clinical ResearchRecruiting
  • ENCORE Borland Groover Clinical ResearchRecruiting
  • ClinCloud LLCRecruiting
  • Panax Clinical ResearchRecruiting
  • Clinical Pharmacology of Miami, LLCRecruiting
  • La Salud ResearchRecruiting
  • Genoma Research Group, IncRecruiting
  • Sensible Healthcare, LLCRecruiting
  • Theia Clinical Research, LLCRecruiting
  • Progressive Medical ResearchRecruiting
  • ClinCloud, LLCRecruiting
  • Metabolic Research Institute, Inc.Recruiting
  • Conquest ResearchRecruiting
  • ASHA Clinical ResearchRecruiting
  • Indiana University (IU) School of MedicineRecruiting
  • Delta Research PartnersRecruiting
  • Tandem Clinical ResearchRecruiting
  • Tandem Clinical Research GIRecruiting
  • Louisiana Research Center, LLCRecruiting
  • The National Diabetes & Obesity Research InstituteRecruiting
  • Jubilee Clinical Research, Inc.Recruiting
  • Sierra Clinical ResearchRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Tandem Clinical Research GIRecruiting
  • Lucas Research - Diabetes & Endocrinology Consultants, PCRecruiting
  • Consultants for Clinical ResearchRecruiting
  • Rapid City Medical CenterRecruiting
  • ClinSearch LLCRecruiting
  • Texas Clinical Research InstituteRecruiting
  • American Research CorporationRecruiting
  • Pinnacle Clinical ResearchRecruiting
  • Pioneer Research Solutions Inc.Recruiting
  • R & H Clinical ResearchRecruiting
  • EPIC Medical ResearchRecruiting
  • American Research CorporationRecruiting
  • Endeavor Clinical TrialsRecruiting
  • Pinnacle Clinical ResearchRecruiting
  • R & H Clinical ResearchRecruiting
  • Simcare Medical Research, LLCRecruiting
  • Impact Clinical ResearchRecruiting
  • Velocity - Advanced Clinical Research - Salt Lake City of GastroenterologRecruiting
  • Manassas Clinical Research CenterRecruiting
  • Virginia Commonwealth University Medical College of VirginiaRecruiting
  • Flinders Medical CentreRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Monash Medical CentreRecruiting
  • Concord Repatriation General HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • University of Calgary Liver UnitRecruiting
  • LMC Diabetes & Endocrinology LtdRecruiting
  • Toronto Liver CentreRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • CHU Grenoble-Alpes - Hopital MichallonRecruiting
  • Hôpital de la Croix Rousse - HCLRecruiting
  • CHU de Montpellier - Hopital Saint EloiRecruiting
  • AP-HP Hopital Saint AntoineRecruiting
  • CHU Bordeaux - Hopital Haut-LevequeRecruiting
  • AP-HP Hopital Paul BrousseRecruiting
  • ID ClinicRecruiting
  • Fundacion de Investigacion (FDI)Recruiting
  • King's College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AXA1125 22.6g

AXA1125 33.9g

Placebo

Arm Description

22.6 g AXA1125 administered orally BID with or without food

33.9 g AXA1125 administered orally BID with or without food

Matching Placebo administered orally BID with or without food

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resolution of NASH without worsening of fibrosis
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
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)
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)

Full Information

First Posted
May 3, 2021
Last Updated
September 7, 2022
Sponsor
Axcella Health, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04880187
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axcella Health, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis (NASH)
Keywords
Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids, Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
273 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXA1125 22.6g
Arm Type
Experimental
Arm Description
22.6 g AXA1125 administered orally BID with or without food
Arm Title
AXA1125 33.9g
Arm Type
Experimental
Arm Description
33.9 g AXA1125 administered orally BID with or without food
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo administered orally BID with or without food
Intervention Type
Drug
Intervention Name(s)
AXA1125
Intervention Description
AXA1125 administered BID with or without food
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo administered BID with or without food
Primary Outcome Measure Information:
Title
Improvement in steatohepatitis
Description
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
Time Frame
Baseline to Week 48
Secondary Outcome Measure Information:
Title
Resolution of NASH without worsening of fibrosis
Description
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.
Time Frame
Baseline to week 48
Title
Improvement of fibrosis by one stage without worsening of NASH
Description
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.
Time Frame
Baseline to week 48
Title
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Baseline to week 48
Title
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Time Frame
Baseline to week 48
Title
Change from baseline in hepatic fat as measured by MRI
Time Frame
Baseline to week 48
Title
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Time Frame
Baseline to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Koziel, MD
Phone
(857) 320-3200
Email
clinicaltrials@axcellahealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Harrison, MD
Organizational Affiliation
Pinnacle Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Individual Site Status
Recruiting
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Name
San Fernando Valley Health Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Individual Site Status
Recruiting
Facility Name
National Research Institute
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
OM Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Research Institute, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa Bay Medical Research , Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
Evolution Clinical Trials, Inc.
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Individual Site Status
Recruiting
Facility Name
ENCORE Borland Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Individual Site Status
Recruiting
Facility Name
La Salud Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Genoma Research Group, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Theia Clinical Research, LLC
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32124
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud, LLC
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Individual Site Status
Recruiting
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
ASHA Clinical Research
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46324
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University (IU) School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Delta Research Partners
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research GI
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Name
The National Diabetes & Obesity Research Institute
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Individual Site Status
Recruiting
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research GI
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucas Research - Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Rapid City Medical Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Name
American Research Corporation
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
R & H Clinical Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Name
EPIC Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
R & H Clinical Research
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Individual Site Status
Recruiting
Facility Name
Simcare Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Name
Impact Clinical Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Recruiting
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of Calgary Liver Unit
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
LMC Diabetes & Endocrinology Ltd
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Nova Scotia Health Authority
City
Halifax
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Grenoble-Alpes - Hopital Michallon
City
La Tronche
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Croix Rousse - HCL
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Montpellier - Hopital Saint Eloi
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Saint Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Haut-Leveque
City
Pessac
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Paul Brousse
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Name
ID Clinic
City
Myslowice
State/Province
CET
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fundacion de Investigacion (FDI)
City
San Juan
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.emmpacttrial.com
Description
EMMPACT Phase 2b Clinical Trial Homepage

Learn more about this trial

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

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