Aramchol in NASH

ARREST Study: Phase 2b of Aramchol in NASH
Ratziu V, AASLD 2018, Abs. LB5

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Design

  • Aramchol: stearoyl-CoA desaturase receptor modulator

Endpoints

  • Primary: absolute change in liver triglycerides
  • Secondary: decrease in fibrosis ≥ 1, NASH resolution

Reduction in liver fat

  • Absolute change from baseline vs placebo:
    • 400 mg: -3.32% ; p = 0.0450
    • 600 mg: -3.09% ; p = 0.0655

ALT statistically significant, drops pretty modest over a year

ALT normalization (%)

  • Effect similar for AST
  • Statistically significant reductions in GGT and Alkaline phosphatase in both groups vs placebo

NASH resolution without worsening of fibrosis, %

  • In subgroups of F2/3, NAS > 4 ; Abnormal AST/AST, BMI > 30 ; HbA1C > 6,4% : NASH resolution was noted in a larger proportion of patients in the 600 mg aramchol group vs placebo

Fibrosis improvement (> 1 stage) without worsening of NASH, %

Progression to cirrhosis, %

  • F2/3, NAS > 4 ; Abnormal AST/AST, BMI ≥ 30 ; HbA1C ≥ 6.4%: fibrosis improvement was noted in a larger proportion of patients in the 600 mg aramchol group vs placebo
  • Abnormal ALT/AST and BMI ≥ 30: Significant difference between placebo and 600 mg aramchol