Non Alcoholic Steatohepatitis (NASH)Phase 2NCT04880187
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
A Phase 2 study testing AXA1125 in people with Non Alcoholic Steatohepatitis (NASH), run by Axcella Health, Inc at 75 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Steatohepatitis (NASH)
- What is being tested?
- AXA1125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 75 sitesin 7 countries
- Study dates
- 7 May 2021to Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Trial locations and contacts
75 sites in 7 countries.
75 sites in 7 countries
United States57 sites, 57 recruiting
- Recruiting
Texas Clinical Research Institute
Arlington, Texas, 76012
- Recruiting
American Research Corporation
Austin, Texas, 78757
- Recruiting
Pinnacle Clinical Research
Austin, Texas, 78757
- Recruiting
Delta Research Partners
Bastrop, Louisiana, 71201
- Recruiting
The National Diabetes & Obesity Research Institute
Biloxi, Mississippi, 39532
- Recruiting
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434
- Recruiting
Synergy Healthcare
Bradenton, Florida, 34208
- Recruiting
San Fernando Valley Health Institute
Canoga Park, California, 91304
- Recruiting
ClinSearch LLC
Chattanooga, Tennessee, 37421
- Recruiting
Consultants for Clinical Research
Cincinnati, Ohio, 45219
- Recruiting
Tampa Bay Medical Research , Inc.
Clearwater, Florida, 33761
- Recruiting
Cullman Clinical Trials
Cullman, Alabama, 35055
- Recruiting
National Research Institute
Gardena, California, 90247
- Recruiting
ASHA Clinical Research
Hammond, Indiana, 46324
- Recruiting
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016
- Recruiting
Pioneer Research Solutions Inc.
Houston, Texas, 77099
- Recruiting
National Research Institute
Huntington Park, California, 90255
- Recruiting
Indiana University (IU) School of Medicine
Indianapolis, Indiana, 46202
- Recruiting
Westside Center for Clinical Research
Jacksonville, Florida, 32205
- Recruiting
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
- Recruiting
R & H Clinical Research
Katy, Texas, 77494
- Recruiting
OM Research LLC
Lancaster, California, 93534
- Recruiting
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106
- Recruiting
Sierra Clinical Research
Las Vegas, Nevada, 89106
- Recruiting
National Research Institute
Los Angeles, California, 90057
- Recruiting
ClinCloud LLC
Maitland, Florida, 32751
- Recruiting
Manassas Clinical Research Center
Manassas, Virginia, 20110
- Recruiting
Tandem Clinical Research
Marrero, Louisiana, 70072
- Recruiting
Tandem Clinical Research GI
Metairie, Louisiana, 70006
- Recruiting
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616
- Recruiting
La Salud Research
Miami, Florida, 33155
- Recruiting
Genoma Research Group, Inc
Miami, Florida, 33173
- Recruiting
Panax Clinical Research
Miami Lakes, Florida, 33014
- Recruiting
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Tandem Clinical Research GI
New York, New York, 10033
- Recruiting
Sensible Healthcare, LLC
Ocoee, Florida, 34761
- Recruiting
Theia Clinical Research, LLC
Pinellas Park, Florida, 33709
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32124
- Recruiting
Rapid City Medical Center
Rapid City, South Dakota, 57701
- Recruiting
EPIC Medical Research
Red Oak, Texas, 75154
- Recruiting
Inland Empire Liver Foundation
Rialto, California, 92377
- Recruiting
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, 23298
- Recruiting
Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog
Riverton, Utah, 84065
- Recruiting
American Research Corporation
San Antonio, Texas, 78215
- Recruiting
Endeavor Clinical Trials
San Antonio, Texas, 78229
- Recruiting
Pinnacle Clinical Research
San Antonio, Texas, 78229
- Recruiting
Precision Research Institute, LLC
San Diego, California, 92114
- Recruiting
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
- Recruiting
R & H Clinical Research
Stafford, Texas, 77477
- Recruiting
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
- Recruiting
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
- Recruiting
Del Sol Research Management, LLC
Tucson, Arizona, 85715
- Recruiting
ClinCloud, LLC
Viera, Florida, 32940
- Recruiting
Impact Clinical Research
Waco, Texas, 76710
- Recruiting
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
- Recruiting
Conquest Research
Winter Park, Florida, 32789
France6 sites, 6 recruiting
- Recruiting
CHU Grenoble-Alpes - Hopital Michallon
La Tronche
- Recruiting
Hôpital de la Croix Rousse - HCL
Lyon
- Recruiting
CHU de Montpellier - Hopital Saint Eloi
Montpellier
- Recruiting
AP-HP Hopital Saint Antoine
Paris
- Recruiting
CHU Bordeaux - Hopital Haut-Leveque
Pessac
- Recruiting
AP-HP Hopital Paul Brousse
Villejuif
Australia5 sites, 5 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane
- Recruiting
Monash Medical Centre
Clayton
- Recruiting
Concord Repatriation General Hospital
Concord
- Recruiting
Fiona Stanley Hospital
Murdoch
Canada4 sites, 4 recruiting
- Recruiting
University of Calgary Liver Unit
Calgary, Alberta
- Recruiting
Nova Scotia Health Authority
Halifax
- Recruiting
LMC Diabetes & Endocrinology Ltd
London, Ontario
- Recruiting
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Puerto Rico1 site, 1 recruiting
- Recruiting
Fundacion de Investigacion (FDI)
San Juan
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
About this study
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)
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)
- Being tested
- AXA1125, Placebo
- Keywords
- Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids, Fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXA1125Drug
AXA1125 administered BID with or without food
PlaceboDrug
Matching Placebo administered BID with or without food
| Study group | Role | What they receive |
|---|---|---|
| AXA1125 22.6g | Experimental | 22.6 g AXA1125 administered orally BID with or without food Receives: Drug: AXA1125 |
| AXA1125 33.9g | Experimental | 33.9 g AXA1125 administered orally BID with or without food Receives: Drug: AXA1125 |
| Placebo | Placebo comparator | Matching Placebo administered orally BID with or without food Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 48
Secondary outcomes (6)
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.
Measured: Baseline to week 48
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.
Measured: Baseline to week 48
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to week 48
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Measured: Baseline to week 48
Change from baseline in hepatic fat as measured by MRI
Measured: Baseline to week 48
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Measured: Baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 May 2021
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axcella Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Harrison, MD, Principal investigator, Pinnacle Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880187
- Sponsor's protocol ID
- AXA1125-101
- Status last verified
- May 2022
- First submitted
- 3 May 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04880187
- Acronym / sponsor ID
- AXA1125-101
- Conditions
- Non Alcoholic Steatohepatitis (NASH)
- Keywords
- Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Axcella Health, IncIndustry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AXA1125 22.6g | Experimental | Drug: AXA112522.6 g AXA1125 administered orally BID with or without food |
| AXA1125 33.9g | Experimental | Drug: AXA112533.9 g AXA1125 administered orally BID with or without food |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo administered orally BID with or without food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- History or presence of liver disease (other than NAFLD or NASH)
- History or presence of cirrhosis and/or history or presence of hepatic decompensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXA1125AXA1125 administered BID with or without food | Drug | AXA1125 22.6g, AXA1125 33.9g |
| PlaceboMatching Placebo administered BID with or without food | Drug | Placebo |
Primary outcome
Improvement in steatohepatitis
Time frame: 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
6 secondary outcomes
Resolution of NASH without worsening of fibrosis
Time frame: Baseline to week 48
Improvement of fibrosis by one stage without worsening of NASH
Time frame: Baseline to week 48
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to week 48
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Time frame: Baseline to week 48
Change from baseline in hepatic fat as measured by MRI
Time frame: Baseline to week 48
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Time frame: Baseline to week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- EMMPACT Phase 2b Clinical Trial HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Harrison, MD principal investigator
Pinnacle Clinical Research
75 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXA1125 in people with Non Alcoholic Steatohepatitis (NASH), run by Axcella Health, Inc at 75 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, France, Australia, Canada, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margaret Koziel, MD ((857) 320-3200, clinicaltrials@axcellahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in steatohepatitis (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.