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

Overview

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.

Full Title of Study: “A 12-Week, Single-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Physiological Regulation of an Amino Acid Food Product, AXA1665, in Subjects With Mild and Moderate Hepatic Insufficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 20, 2020

Interventions

  • Dietary Supplement: AXA1665
    • Dietary supplement: AXA1665
  • Dietary Supplement: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Active Comparator: AXA1665 29.4g
    • Dietary Supplement: AXA1665 Amino acids, food study
  • Active Comparator: AXA1665 53.9 g
    • Dietary Supplement: AXA1665 Amino acids, food study
  • Placebo Comparator: Placebo 29.4 g
    • Dietary Supplement: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
    • Time Frame: Baseline to Week 12

Secondary Measures

  • Change in muscle mass by MRI
    • Time Frame: Baseline to Week 12
  • Change in Fischer’s ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)]
    • Time Frame: Baseline to Week 12
  • Change in plasma ammonia
    • Time Frame: Baseline to Week 12
  • Change in blood urea nitrogen concentration
    • Time Frame: Baseline to Week 12
  • Change in creatinine concentration
    • Time Frame: Baseline to Week 12
  • Change in gait speed
    • Time Frame: Baseline to Week 12
  • Change in Liver Frailty Index
    • Time Frame: Baseline to Week 12
  • Change in overall physical activity (measured by actigraphy watch)
    • Time Frame: Baseline to Week 12
  • Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)
    • Time Frame: Baseline to Week 12

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axcella Health, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arun J Sanyal, MD, Principal Investigator, Virginia Commonwealth University

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