NOW RECRUITING: PHASE 2B CLINICAL TRIAL
Have you or a loved one been diagnosed with NASH?
You or your loved one could be eligible to participate in a global clinical trial of an investigational NASH treatment.
It has been estimated that NASH, an advanced form of fatty liver disease, impacts up to 6% of the world’s population, or nearly 500 million people. Yet, there are no approved NASH medications in most countries around the world, including the U.S.
About the EMMPACT Phase 2b Clinical Trial in NASH
EMMPACT (#NCT04880187) is being conducted to investigate the effectiveness and safety of AXA1125, an investigational (not approved) new drug that is administered as a drink for subjects with NASH.
The trial compares two doses of AXA1125 versus a placebo over a 48-week treatment period and a four-week safety follow-up period. Approximately 270 subjects with NASH are being enrolled across more than 70 clinical sites around the world.
The trial will seek to determine whether AXA1125 is able to reduce liver injury in subjects with NASH and will assess its safety and tolerability compared to placebo.
Subjects who participate in EMMPACT will receive:
AXA1125 for 48 weeks if assigned to the active drug (2 of every 3 subjects to receive active drug)
Trial-related monitoring and care from a physician who has NASH experience
Trial-related medical tests
- Be at least 18 years of age
- Undergo (or have recently undergone) a liver biopsy, which is a procedure to remove a small piece of liver tissue for analysis
- Have NASH and some evidence of liver scarring (fibrosis)
- Have a history or presence of a liver disease other than NASH
- Have a history or presence of cirrhosis (advanced liver scarring)
Non-alcoholic steatohepatitis (NASH) is a condition that involves a build-up of fat and inflammation in the liver. As a result of these issues, some NASH patients also develop liver scarring and an even more severe condition known as cirrhosis. Many people do not have any symptoms of NASH and are unaware of the condition until undergoing blood or imaging tests that a physician does for other reasons. This disease is known to cause serious health problems, including liver cancer, the need for a liver transplant and death from liver failure.
While the cause of NASH is not known, it is thought to be related to how the body breaks down sugars and fats. It is seen more frequently in people who have other metabolic problems, such as Type II diabetes, obesity and hyperlipidemia (high levels of fat in the blood).
Currently, there are no approved NASH medications in most countries, including the U.S. Current treatments mainly aim to control diet and promote physical activity.
Anyone with NASH should avoid alcohol and other potential causes of damage to the liver.
Symptoms of NASH
- Pain around liver
- Issues Sleeping
AXA1125 is a proprietary mixture of six amino acids, which are small molecules that make up the building blocks of proteins in the body. Amino acids are a normal part of the human diet and naturally influence many of the body's systems.
AXA1125 is a dry powder that is simply mixed with a small amount of water and drunk by the subject. The EMMPACT trial is seeking to determine this product candidate’s ability to work with the body’s system to reduce liver injury and will assess its safety and tolerability compared to placebo in subjects with NASH.
AXA1125 is an investigational new drug that has not been approved for the treatment of NASH by any regulatory authority.
The EMMPACT trial is being conducted globally across more than 70 clinical sites.