In a recent trial, Galmed Pharmaceuticals’ Aramchol showed promise in reducing liver fat among those with non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, Healio reports.
Presenting their findings at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco (The Liver Meeting), researchers conducted a Phase IIb trial of Aramchol treatment among 247 people who had NASH according to a biopsy. These individuals were also overweight or obese and had prediabetes or diabetes.
The participants were randomized to receive a daily regimen of 400 milligrams (101 people) or 600 mg (98 people) of Aramchol or to receive a placebo (48 people).
After one year of treatment, liver fat declined significantly in those receiving 400 mg of Aramchol and showed a trend of significant decline in those receiving 600 mg of the drug.
Liver fat declined by at least 5 percent in 47 percent of those in the 600 mg group, 37 percent in the 400 mg group and 24 percent in the placebo group. These findings suggested that the drug’s effect were dose-respondent, meaning that a higher dose yielded a greater effect.
A total of 16.7 percent of those in the 600 mg group saw their NASH resolve while their liver fibrosis did not worsen, compared with 5 percent of those in the placebo group. This meant that the 600 mg dose was associated with a 4.7-fold increased likelihood of NASH resolution.
Those in both dosing groups saw a significant reduction in their ALT and AST liver enzymes compared with those in the placebo group. Again, the results were dose-respondent.
Less than 5 percent of participants discontinued treatment due to adverse health events. Ten percent of participants experienced serious adverse health events. There was no difference between the dosing groups on these measures.
To read the Healio article, click here.