Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Non Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880187
• Other study ID #: AXA1125-101
• Status: Recruiting
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: Axcella Health, Inc
• Contact: Margaret Koziel, MD
• Phone: (857) 320-3200
• Email: clinicaltrials[@]axcellahealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 273
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing to participate in the study and provide written informed consent.
• Male and female adults aged > 18 years.
• Must have NASH and fibrosis on a liver biopsy sample
• If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
• Subjects may have a diagnosis of T2DM

Exclusion Criteria:

• History or presence of liver disease (other than NAFLD or NASH)
• History or presence of cirrhosis and/or history or presence of hepatic decompensation

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Non Alcoholic Steatohepatitis (NASH)
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• AXA1125
AXA1125 administered BID with or without food
• Placebo
Matching Placebo administered BID with or without food

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park
Australia	Royal Brisbane and Women's Hospital	Brisbane
Australia	Monash Medical Centre	Clayton
Australia	Concord Repatriation General Hospital	Concord
Australia	Fiona Stanley Hospital	Murdoch
Canada	University of Calgary Liver Unit	Calgary	Alberta
Canada	Nova Scotia Health Authority	Halifax
Canada	LMC Diabetes & Endocrinology Ltd	London	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
France	CHU Grenoble-Alpes - Hopital Michallon	La Tronche
France	Hôpital de la Croix Rousse - HCL	Lyon
France	CHU de Montpellier - Hopital Saint Eloi	Montpellier
France	AP-HP Hopital Saint Antoine	Paris
France	CHU Bordeaux - Hopital Haut-Leveque	Pessac
France	AP-HP Hopital Paul Brousse	Villejuif
Poland	ID Clinic	Myslowice	CET
Puerto Rico	Fundacion de Investigacion (FDI)	San Juan
United Kingdom	King's College Hospital	London
United States	Texas Clinical Research Institute	Arlington	Texas
United States	American Research Corporation	Austin	Texas
United States	Pinnacle Clinical Research	Austin	Texas
United States	Delta Research Partners	Bastrop	Louisiana
United States	The National Diabetes & Obesity Research Institute	Biloxi	Mississippi
United States	Excel Medical Clinical Trials, LLC	Boca Raton	Florida
United States	Synergy Healthcare	Bradenton	Florida
United States	San Fernando Valley Health Institute	Canoga Park	California
United States	ClinSearch LLC	Chattanooga	Tennessee
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Tampa Bay Medical Research , Inc.	Clearwater	Florida
United States	Cullman Clinical Trials	Cullman	Alabama
United States	National Research Institute	Gardena	California
United States	ASHA Clinical Research	Hammond	Indiana
United States	Evolution Clinical Trials, Inc.	Hialeah Gardens	Florida
United States	Pioneer Research Solutions Inc.	Houston	Texas
United States	National Research Institute	Huntington Park	California
United States	Indiana University (IU) School of Medicine	Indianapolis	Indiana
United States	ENCORE Borland Groover Clinical Research	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	R & H Clinical Research	Katy	Texas
United States	OM Research LLC	Lancaster	California
United States	Jubilee Clinical Research, Inc.	Las Vegas	Nevada
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	National Research Institute	Los Angeles	California
United States	ClinCloud LLC	Maitland	Florida
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Tandem Clinical Research GI	Metairie	Louisiana
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Genoma Research Group, Inc	Miami	Florida
United States	La Salud Research	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Lucas Research - Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Tandem Clinical Research GI	New York	New York
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Theia Clinical Research, LLC	Pinellas Park	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Rapid City Medical Center	Rapid City	South Dakota
United States	EPIC Medical Research	Red Oak	Texas
United States	Inland Empire Liver Foundation	Rialto	California
United States	Virginia Commonwealth University Medical College of Virginia	Richmond	Virginia
United States	Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog	Riverton	Utah
United States	American Research Corporation	San Antonio	Texas
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Precision Research Institute, LLC	San Diego	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	R & H Clinical Research	Stafford	Texas
United States	Simcare Medical Research, LLC	Sugar Land	Texas
United States	Adobe Clinical Research, LLC	Tucson	Arizona
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	ClinCloud, LLC	Viera	Florida
United States	Impact Clinical Research	Waco	Texas
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Axcella Health, Inc

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Poland,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in steatohepatitis	2-point improvement from baseline to Week 48 in the non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) based on a scale from 0-8 with 0 being no NASH and 8 being the highest score	Baseline to Week 48
Secondary	Resolution of NASH without worsening of fibrosis	The proportion of subjects with resolution of NASH with no worsening of fibrosis defined as a post-treatment ballooning score of 0 and an inflammation score of 0 or 1 on liver biopsy.	Baseline to week 48
Secondary	Improvement of fibrosis by one stage without worsening of NASH	The proportion of subjects who have at least a 1-stage improvement in fibrosis and no worsening of NASH based on liver biopsy 0 being no fibrosis and 4 being the worse.	Baseline to week 48
Secondary	Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)		Baseline to week 48
Secondary	Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)		Baseline to week 48
Secondary	Change from baseline in hepatic fat as measured by MRI		Baseline to week 48
Secondary	Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)		Baseline to week 48

External Links

•   EMMPACT Phase 2b Clinical Trial Homepage