NAFLDNCT04073368
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
A study testing AXA1957 and AXA1125 in people with NAFLD, run by Axcella Health, Inc at 18 sites in United States.
Trial summary
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study will also examine liver biology using blood tests and magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD
- What is being tested?
- AXA1957 and AXA1125
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 18 sitesUnited States
- Study dates
- 3 Dec 2018to 3 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 3 months prior to Screening.
- A screening MRI consistent with liver inflammation and fibrosis.
Who cannot join
- Current or history of significant alcohol consumption.
- History or presence of liver disease (other than NAFLD/NASH).
- History or presence of cirrhosis and/or history or presence of hepatic decompensation.
- Any diabetes other than Type 2.
- Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg).
- Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.).
Show all 9Show fewer
- Unable or unwilling to adhere to contraception requirements.
- Any contraindications to a MRI scan.
- Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pinnacle Clinical Research
Austin, Texas, 73301
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33427
The Institute for Liver Health LLC
Chandler, Arizona, 85224
Liver Center of Texas
Dallas, Texas, 75234
Doctors Hospital at Renaissance, LLC
Edinburg, Texas, 78504
Texas Digestive Disease Consultants (TDDC) - Downtown Fort Worth
Fort Worth, Texas, 76104
Gastro One
Germantown, Tennessee, 20874
National Research Institute
Huntington Park, California, 90255
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, 39056
Kansas City Research Institute
Kansas City, Missouri, 64030
Florida Digestive Health Specialists
Lakewood Rch, Florida, 34202
National Research Institute - Wilshire
Los Angeles, California, 90010
Catalina Research Institute, LLC
Montclair, California, 91762
Compass Research, LLC - Orlando
Orlando, Florida, 32789
Bioclinica Research
Orlando, Florida, 32806
National Research Institute - Panorama
Panorama City, California, 91402
Pinnacle Clinical Research
San Antonio, Texas, 78201
The Institute for Liver Health LLC
Tucson, Arizona, 85641
About this study
Official title: A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study will also examine liver biology using blood tests and magnetic resonance imaging (MRI).
Read the detailed description
This was a 16-week, single-blind, randomized, placebo-controlled food study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD.
Subjects signed an informed consent form and were screened for eligibility, per the inclusion and exclusion criteria below, up to 6 weeks before the start of the administration period. Subjects were randomized as soon as eligibility was confirmed.
Eligible subjects were randomized in a 2:2:2:1 ratio to receive either AXA1125 24 g twice daily (BID), AXA1957 20.3 g BID, AXA1957 13.5 g BID, or placebo 24 g BID. Randomization occurred via an interactive web response system after eligibility was confirmed and approximately 3 to 5 days prior to the Day 1 visit. Assigned study food product (AXA1125, AXA1957, or placebo) were shipped to the study site upon randomization of each subject.
Once randomization had occurred, subjects presented to the study site on Day 1 (Baseline/Visit 2) for their baseline assessments per the schedule of events. Study Day 1 was the beginning of the 16-week administration period.
Subjects returned to the study site at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6), Week 12 (Visit 7), and Week 16 (Visit 8) to receive their study food product and/or to return any unused study food product, provide blood samples for biomarker and other laboratory testing, undergo liver imaging, and complete other study safety assessments per the schedule of events.
The Safety Follow-up Visit, which occurred approximately 2 weeks after the last visit in the administration period (ie, after the Week 16 visit or at the time of early termination), was the End of Study Visit (Visit 9).
There were 9 study visits in total, including the Screening and Follow-up Visits.
- Conditions
- NAFLD
- Being tested
- AXA1957, AXA1125, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXA1957Dietary supplement
Amino acids, food study
AXA1125Dietary supplement
Amino acids, food study
PlaceboDietary supplement
Amino acids, food study
| Study group | Role | What they receive |
|---|---|---|
| AXA1957 high dose | Active comparator | AXA1957 20.3g Receives: Dietary Supplement: AXA1957 |
| AXA1957 low dose | Active comparator | AXA1957 13.5g Receives: Dietary Supplement: AXA1957 |
| AXA1125 | Active comparator | AXA1125 24g Receives: Dietary Supplement: AXA1125 |
| Placebo | Placebo comparator | Placebo 24g Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks
Measured: Baseline to week 16
Secondary outcomes (5)
Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)
Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)
Measured: Baseline to week 16
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)
Measured: Baseline to week 16
Change in Glucose Homeostasis
Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)
Measured: Baseline to week 16
Relative Change in Alanine Aminotransferase (ALT)
Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)
Measured: Baseline to week 16
Change in Aspartate Aminotransferase (AST)
Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start3 Dec 2018
- Primary completion31 Mar 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
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
- NCT04073368
- Sponsor's protocol ID
- AXA1125-003
- Status last verified
- Jun 2021
- First submitted
- 27 Aug 2019
- Last updated
- 6 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harrison SA, Baum SJ, Gunn NT, Younes ZH, Kohli A, Patil R, Koziel MJ, Chera H, Zhao J, Chakravarthy MV. Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2021 Dec 1;116(12):2399-2409. doi: 10.14309/ajg.0000000000001375.
PubMed 34382947
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT04073368
- Acronym / sponsor ID
- AXA1125-003
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Axcella Health, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study will also examine liver biology using blood tests and magnetic resonance imaging (MRI).
Detailed description
This was a 16-week, single-blind, randomized, placebo-controlled food study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD.
Subjects signed an informed consent form and were screened for eligibility, per the inclusion and exclusion criteria below, up to 6 weeks before the start of the administration period. Subjects were randomized as soon as eligibility was confirmed.
Eligible subjects were randomized in a 2:2:2:1 ratio to receive either AXA1125 24 g twice daily (BID), AXA1957 20.3 g BID, AXA1957 13.5 g BID, or placebo 24 g BID. Randomization occurred via an interactive web response system after eligibility was confirmed and approximately 3 to 5 days prior to the Day 1 visit. Assigned study food product (AXA1125, AXA1957, or placebo) were shipped to the study site upon randomization of each subject.
Once randomization had occurred, subjects presented to the study site on Day 1 (Baseline/Visit 2) for their baseline assessments per the schedule of events. Study Day 1 was the beginning of the 16-week administration period.
Subjects returned to the study site at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6), Week 12 (Visit 7), and Week 16 (Visit 8) to receive their study food product and/or to return any unused study food product, provide blood samples for biomarker and other laboratory testing, undergo liver imaging, and complete other study safety assessments per the schedule of events.
The Safety Follow-up Visit, which occurred approximately 2 weeks after the last visit in the administration period (ie, after the Week 16 visit or at the time of early termination), was the End of Study Visit (Visit 9).
There were 9 study visits in total, including the Screening and Follow-up Visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AXA1957 high dose | Active comparator | Dietary Supplement: AXA1957AXA1957 20.3g |
| AXA1957 low dose | Active comparator | Dietary Supplement: AXA1957AXA1957 13.5g |
| AXA1125 | Active comparator | Dietary Supplement: AXA1125AXA1125 24g |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 24g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to participate in the study and provide written informed consent.
- Male and female adults aged > 18 years.
- Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 3 months prior to Screening.
- A screening MRI consistent with liver inflammation and fibrosis.
Key exclusion criteria (9 listed)
- Current or history of significant alcohol consumption.
- History or presence of liver disease (other than NAFLD/NASH).
- History or presence of cirrhosis and/or history or presence of hepatic decompensation.
- Any diabetes other than Type 2.
- Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg).
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 |
|---|---|---|
| AXA1957Amino acids, food study | Dietary supplement | AXA1957 high dose, AXA1957 low dose |
| AXA1125Amino acids, food study | Dietary supplement | AXA1125 |
| PlaceboAmino acids, food study | Dietary supplement | Placebo |
Primary outcome
Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Time frame: Baseline to week 16
Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks
5 secondary outcomes
Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)
Time frame: Baseline to week 16
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline to week 16
Change in Glucose Homeostasis
Time frame: Baseline to week 16
Relative Change in Alanine Aminotransferase (ALT)
Time frame: Baseline to week 16
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34382947Harrison SA, Baum SJ, Gunn NT, Younes ZH, Kohli A, Patil R, Koziel MJ, Chera H, Zhao J, Chakravarthy MV. Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2021 Dec 1;116(12):2399-2409. doi: 10.14309/ajg.0000000000001375.
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXA1957 and AXA1125 in people with NAFLD, run by Axcella Health, Inc at 18 sites in United States.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs) (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073368, which also lists 1 linked publication.
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 6 Jul 2021.