NAFLDNCT04073407

Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

A study testing AXA1957 in people with NAFLD, run by Axcella Health, Inc at 4 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI). Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: NAFLD
What is being tested?: AXA1957
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 4 sitesUnited Kingdom
Study dates: 27 Jul 2019to 1 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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Willing to participate in the study and provide written informed consent.
Male and female adolescent subjects aged 12 to 17 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 30 days prior to Screening.
Non alcoholic fatty liver disease
Diabetes or prediabetes
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

4 sites in 1 country.

United Kingdom4 sites

Royal London Children's Hospital
London, E1 1BB
King's College Hospital
London
Royal Manchester Children's Hospital
Manchester
Univeristy of Southhampton
Southampton, S016 6YD

Other trials in United Kingdom

About this study

Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver

Conditions: NAFLD
Being tested: AXA1957, 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
PlaceboDietary supplement
placebo

Study groups in NCT04073407
Study group	Role	What they receive
AXA1957	Active comparator	AXA1957 20.4g Receives: Dietary Supplement: AXA1957
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 Adverse Events (AEs).
Study food product emergent adverse events (AEs). Subjects reporting >or equal to 1 study food product-emergent AE.
Measured: AEs Baseline to week 13 - Part 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 20191 Sep 2020

First posted29 Aug 2019
Study start27 Jul 2019
Primary completion15 Apr 2020
Study completion1 Sep 2020

Why it stopped: Sponsor has determined that information it would have collected would not inform future development of a therapy with AXA 1957 for NAFLD

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.
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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04073407
Sponsor's protocol ID: AXA1957-002
Status last verified: Aug 2021
First submitted: 27 Aug 2019
Last updated: 23 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
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Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

All NAFLD trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver
ClinicalTrials.gov ID: NCT04073407
Acronym / sponsor ID: AXA1957-002
Conditions: NAFLD
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor has determined that information it would have collected would not inform future development of a therapy with AXA 1957 for NAFLD
Enrolment: 9 participants (actual)
Lead sponsor: Axcella Health, IncIndustry (pharma, biotech, devices)
Study start: 27 Jul 2019 (actual)
Primary completion: 15 Apr 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 29 Aug 2019 (actual)
Results: Posted 23 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AXA1957	Active comparator	Dietary Supplement: AXA1957AXA1957 20.4g
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo 24g

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Willing to participate in the study and provide written informed consent.
Male and female adolescent subjects aged 12 to 17 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 30 days prior to Screening.
Non alcoholic fatty liver disease
Diabetes or prediabetes

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
Placeboplacebo	Dietary supplement	Placebo

Primary outcome

Number of Subjects With Adverse Events (AEs).
Time frame: AEs Baseline to week 13 - Part 1
Study food product emergent adverse events (AEs). Subjects reporting >or equal to 1 study food product-emergent AE.

Results and safety

Results posted to the registry on 23 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AXA1957	6	1
Placebo	3	2

Primary outcome: Number of Subjects With Adverse Events (AEs).

Time frame: AEs Baseline to week 13 - Part 1. Count of participants. Unit: Participants

Measure	AXA1957 n = 6	Placebo n = 3
Value	2	1

Population analysed: Safety analysis for Part 1 Baseline to week 13

Adverse events

Time frame: From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXA1957	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for NAFLD

Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

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.

Saul Faust, MBBS MRCPCH PhD principal investigator

University of Southampton

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AXA1957 in people with NAFLD, run by Axcella Health, Inc at 4 sites in United Kingdom.

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 6 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: stopped early, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. 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 23 Sep 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 Adverse Events (AEs). (time frame: AEs Baseline to week 13 - Part 1). 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 NCT04073407.

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 23 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.