Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

NAFLD Clinical Trial

Official title:

A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073368
• Other study ID #: AXA1125-003
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: September 3, 2020

Study information

• Verified date: June 2021
• Source: Axcella Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This was a 16-week, single-blind, randomized, placebo-controlled food study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD.

Subjects signed an informed consent form and were screened for eligibility, per the inclusion and exclusion criteria below, up to 6 weeks before the start of the administration period. Subjects were randomized as soon as eligibility was confirmed.

Eligible subjects were randomized in a 2:2:2:1 ratio to receive either AXA1125 24 g twice daily (BID), AXA1957 20.3 g BID, AXA1957 13.5 g BID, or placebo 24 g BID. Randomization occurred via an interactive web response system after eligibility was confirmed and approximately 3 to 5 days prior to the Day 1 visit. Assigned study food product (AXA1125, AXA1957, or placebo) were shipped to the study site upon randomization of each subject.

Once randomization had occurred, subjects presented to the study site on Day 1 (Baseline/Visit 2) for their baseline assessments per the schedule of events. Study Day 1 was the beginning of the 16-week administration period.

Subjects returned to the study site at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6), Week 12 (Visit 7), and Week 16 (Visit 8) to receive their study food product and/or to return any unused study food product, provide blood samples for biomarker and other laboratory testing, undergo liver imaging, and complete other study safety assessments per the schedule of events.

The Safety Follow-up Visit, which occurred approximately 2 weeks after the last visit in the administration period (ie, after the Week 16 visit or at the time of early termination), was the End of Study Visit (Visit 9).

There were 9 study visits in total, including the Screening and Follow-up Visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 3, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• AXA1957
Amino acids, food study
• AXA1125
Amino acids, food study
• Placebo
Amino acids, food study

Locations

Country	Name	City	State
United States	Pinnacle Clinical Research	Austin	Texas
United States	Excel Medical Clinical Trials, LLC	Boca Raton	Florida
United States	The Institute for Liver Health LLC	Chandler	Arizona
United States	Liver Center of Texas	Dallas	Texas
United States	Doctors Hospital at Renaissance, LLC	Edinburg	Texas
United States	Texas Digestive Disease Consultants (TDDC) - Downtown Fort Worth	Fort Worth	Texas
United States	Gastro One	Germantown	Tennessee
United States	National Research Institute	Huntington Park	California
United States	Southern Therapy and Advanced Research LLC	Jackson	Mississippi
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Florida Digestive Health Specialists	Lakewood Ranch	Florida
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Catalina Research Institute, LLC	Montclair	California
United States	Bioclinica Research	Orlando	Florida
United States	Compass Research, LLC - Orlando	Orlando	Florida
United States	National Research Institute - Panorama	Panorama City	California
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	The Institute for Liver Health LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Axcella Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)	Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks	Baseline to week 16
Secondary	Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)	Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)	Baseline to week 16
Secondary	Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)	Baseline to week 16
Secondary	Change in Glucose Homeostasis	Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)	Baseline to week 16
Secondary	Relative Change in Alanine Aminotransferase (ALT)	Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)	Baseline to week 16
Secondary	Change in Aspartate Aminotransferase (AST)	Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)	Baseline to Week 16