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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AXA1665

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Montclair, California, United States, 91762
      • Catalina Research Institute, LLC
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • Orlando, Florida, United States, 32810
      • OMEGA Research Maitland, LCC
    • Tampa, Florida, United States, 33613
      • Avita Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Delta Research Partners
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Center for Liver Disease
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AXA1665 29.4g; Dietary Supplement: AXA1665 Amino acids, food study	Dietary supplement: AXA1665; Dietary supplement: AXA1665
Active Comparator: AXA1665 53.9 g; Dietary Supplement: AXA1665 Amino acids, food study	Dietary supplement: AXA1665; Dietary supplement: AXA1665
Placebo Comparator: Placebo 29.4 g; Dietary Supplement: Placebo	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in muscle mass by MRI	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)]	Baseline to Week 12
Change in plasma ammonia	Baseline to Week 12
Change in blood urea nitrogen concentration	Baseline to Week 12
Change in creatinine concentration	Baseline to Week 12
Change in gait speed	Baseline to Week 12
Change in Liver Frailty Index	Baseline to Week 12
Change in overall physical activity (measured by actigraphy watch)	Baseline to Week 12
Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Axcella Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Amino acids, food study
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: AXA1665-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No