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The trial is taking place at:
E

Epic Medical Research | Red Oak, TX

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

A

Axcella Health

Status and phase

Enrolling
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

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

Trial contacts and locations

75

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Central trial contact

Margaret Koziel, MD

Data sourced from clinicaltrials.gov

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