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A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

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Trial Profile

A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs AXA 1125 (Primary) ; AXA 1957 (Primary)
  • Indications Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
  • Focus Adverse reactions
  • Sponsors Axcella Health

    • Most Recent Events

    • 14 Nov 2023 Exposure of AXA-1125 was modeled in Monolix using 1-compartment model based on data from a single 22.6 g dose, to predict the exposure of multiple doses (24 g BID) for 16 weeks using Simulx, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 08 Nov 2022 Results assessing plasma protein bio-markers to predict responders to AXA1125 treatment, presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases.
    • 15 Nov 2021 Results assessing the relationship between plasma metabolomic changes and MRI-PDFF improvements in NAFLD subjects treated with AXA1125, presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases

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