NCT04147936

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Axcella Health, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AXA1665	Dietary supplement: AXA1665
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2019-03-30
• Primary completion: 2020-05-20
• Completion: 2020-06-24
• First posted: 2019-11-01
• Last updated: 2020-09-18

Locations

11 sites across 1 country: United States