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

NCT04073368 | Completed Results

• 1 other identifier: AXA1125-003
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 18

Brief 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).

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)

  Baseline to week 16

• Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Baseline to week 16

• Change in Glucose Homeostasis

  Baseline to week 16

• Relative Change in Alanine Aminotransferase (ALT)

  Baseline to week 16

• Change in Aspartate Aminotransferase (AST)

  Baseline to Week 16

Study Arms (4)

AXA1957 high dose

ACTIVE COMPARATOR

AXA1957 20.3g

Dietary Supplement: AXA1957

AXA1957 low dose

ACTIVE COMPARATOR

AXA1957 13.5g

Dietary Supplement: AXA1957

AXA1125

ACTIVE COMPARATOR

AXA1125 24g

Dietary Supplement: AXA1125

Placebo

PLACEBO COMPARATOR

Placebo 24g

Dietary Supplement: Placebo

Interventions

AXA1957 DIETARY_SUPPLEMENT

Amino acids, food study

AXA1957 high dose; AXA1957 low dose

AXA1125 DIETARY_SUPPLEMENT

Amino acids, food study

AXA1125

Placebo DIETARY_SUPPLEMENT

Amino acids, food study

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axcella Health, Inc: lead

Study Sites (18)

The Institute for Liver Health LLC

Chandler, Arizona, 85224, United States

Location

The Institute for Liver Health LLC

Tucson, Arizona, 85641, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

National Research Institute - Wilshire

Los Angeles, California, 90010, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91762, United States

Location

National Research Institute - Panorama

Panorama City, California, 91402, United States

Location

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, 33427, United States

Location

Florida Digestive Health Specialists

Lakewood Rch, Florida, 34202, United States

Location

Compass Research, LLC - Orlando

Orlando, Florida, 32789, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39056, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64030, United States

Location

Gastro One

Germantown, Tennessee, 20874, United States

Location

Pinnacle Clinical Research

Austin, Texas, 73301, United States

Location

Liver Center of Texas

Dallas, Texas, 75234, United States

Location

Doctors Hospital at Renaissance, LLC

Edinburg, Texas, 78504, United States

Location

Texas Digestive Disease Consultants (TDDC) - Downtown Fort Worth

Fort Worth, Texas, 76104, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 78201, United States

Location

Related Publications (1)

• Harrison SA, Baum SJ, Gunn NT, Younes ZH, Kohli A, Patil R, Koziel MJ, Chera H, Zhao J, Chakravarthy MV. Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2021 Dec 1;116(12):2399-2409. doi: 10.14309/ajg.0000000000001375.

  PMID: 34382947 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

leucine, isoleucine, valine, arginine, glutamine, and N-acetylcysteine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Margaret Koziel, MD
• Organization: Axcella Health, Inc

clinicaltrials@axcellahealth.com

8573202200

Study Officials

• Stephen Harrison, MD

  Pinnacle Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: December 3, 2018
• Primary Completion: March 31, 2020
• Study Completion: September 3, 2020
• Last Updated: July 6, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Locations

US (18)