Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency

Axcella Health

Status: Completed

Conditions: Hepatic Insufficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AXA1665

Study type: Interventional

Funder types: Industry

Identifiers

NCT04147936

AXA1665-002

Details and patient eligibility

About

This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to participate in the study and provide written informed consent
• Male and female adults aged > 18 years
• Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
• Liver Frailty Index (LFI) of ≥3.6
• Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week

Exclusion criteria

• Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
• Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
• Current or history of significant alcohol consumption
• Other poorly controlled medical condition [e.g., renal disease with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2)
• Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
• Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

AXA1665 29.4g

Active Comparator group

Description:

Dietary Supplement: AXA1665 Amino acids, food study

Treatment:

Dietary Supplement: AXA1665

AXA1665 53.9 g

Active Comparator group

Description:

Dietary Supplement: AXA1665 Amino acids, food study

Treatment:

Dietary Supplement: AXA1665

Placebo 29.4 g

Placebo Comparator group

Description:

Dietary Supplement: Placebo

Treatment:

Dietary Supplement: Placebo