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

Axcella Health

Status and phase: Unknown; Phase 2

Conditions: Non Alcoholic Steatohepatitis (NASH)

Treatments: Drug: AXA1125; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04880187

AXA1125-101

Details and patient eligibility

About

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.

Enrollment: 273 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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273 participants in 3 patient groups, including a placebo group

AXA1125 22.6g

Experimental group

Description:

22.6 g AXA1125 administered orally BID with or without food

Treatment:

Drug: AXA1125

AXA1125 33.9g

Experimental group

Description:

33.9 g AXA1125 administered orally BID with or without food

Treatment:

Drug: AXA1125

Placebo

Placebo Comparator group

Description:

Matching Placebo administered orally BID with or without food

Treatment:

Drug: Placebo