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.
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
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
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).
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Axcella Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saul Faust, MBBS MRCPCH PhD, Principal investigator, University of Southampton
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
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.
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).
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
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.
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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.
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?
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.