N/A
N=102
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD
Bottom Line
View on ClinicalTrials.gov: NCT04073368 ↗Enrolled (actual)
102
Serious AEs
2.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs) — 10; 8; 13; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AXA1957 (Dietary_supplement); AXA1125 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axcella Health, Inc
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs) |
10; 8; 13; 2; 1; 0 | — |
| SECONDARY Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF) |
-8.12; -20.29; -22.88; -5.74 | — |
| SECONDARY Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
8.421; 1.445; -4.369; 0.720 | — |
| SECONDARY Change in Glucose Homeostasis |
0.0138; .0001; -0.0070; -0.0027 | — |
| SECONDARY Relative Change in Alanine Aminotransferase (ALT) |
-20.65; -19.19; -21.86; -7.20 | — |
| SECONDARY Change in Aspartate Aminotransferase (AST) |
-13.40; -17.02; -16.76; -7.49 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04073368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.