Status:
TERMINATED
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Axcella Health, Inc
Conditions:
NAFLD
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief 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 disea...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.),
- 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
Key Trial Info
Start Date :
July 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04073407
Start Date
July 27 2019
End Date
September 1 2020
Last Update
September 23 2021
Active Locations (4)
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1
Royal London Children's Hospital
London, United Kingdom, E1 1BB
2
King's College Hospital
London, United Kingdom
3
Royal Manchester Children's Hospital
Manchester, United Kingdom
4
Univeristy of Southhampton
Southampton, United Kingdom, S016 6YD