Status:
COMPLETED
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Axcella Health, Inc
Conditions:
NAFLD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04073368
Start Date
December 3 2018
End Date
September 3 2020
Last Update
July 6 2021
Active Locations (18)
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1
The Institute for Liver Health LLC
Chandler, Arizona, United States, 85224
2
The Institute for Liver Health LLC
Tucson, Arizona, United States, 85641
3
National Research Institute
Huntington Park, California, United States, 90255
4
National Research Institute - Wilshire
Los Angeles, California, United States, 90010