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Non-alcoholic fatty liver disease (NAFLD) is an increasingly common disease in the general population.
Non-alcoholic fatty liver diabetes
NASH is a progressive form of non-alcoholic fatty liver, which is characterized by the accumulation of liver fat, liver cell damage (hepatocyte swelling) and liver inflammation
Metabolic syndrome
Currently, there are no approved therapies for the treatment of NASH, and ongoing late-stage clinical trials are aimed at testing histological improvements, such as resolution of steatohepatitis or resolution of fibrosis, and long-term outcome trials will evaluate these histological improvements.
Aramchol is a partial inhibitor of liver stearoyl-CoA desaturase (SCD1) .
Aramchol is a partial inhibitor of liver stearoyl-CoA desaturase (SCD1) Aramchol is a partial inhibitor of liver stearoyl-CoA desaturase (SCD1) The most recent ARREST is a 52-week period The double-blind, placebo-controlled Phase 2b trial of 247 NASH patients was randomized.
Histological and biochemical efficacy results
Histological and biochemical efficacy results
Aramchol 600 mg produced a placebo-corrected drop in liver triglycerides, but did not reach the pre-specified significance Aramchol 600 mg produced a placebo-corrected drop in liver triglycerides, but did not reach the pre-specified significance
The placebo-adjusted ALT drop for 600 mg of Aramchol was -29.
Aramchol 600 and 400 mg are safe and well tolerated Aramchol 600 and 400 mg are safe and well tolerated
Therefore, although the primary endpoint of Aramchol's 600 mg liver fat reduction did not reach the pre-determined significance level, the observed safety and liver histology and enzyme changes are promising for SCD1 regulation as a kind of NASH and fibrosis The therapy provided the rationale, and the evaluation of the Phase 3 project is underway
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Original source:V.
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