Liver cirrhosis due to fatty liver is the most common indication for liver transplantation in the United States in people over 65 years of age and in women. Although there are several drugs in development for the treatment of fatty liver, none of them have yet been approved for use.
In March 2024, a study has been published in the Hepatology journal concerning a new drug (aldafermin) that was administered to patients with cirrhosis due to fatty liver.
This study included 153 patients diagnosed with fatty liver cirrhosis by liver biopsy. Patients were divided into three groups that received aldafermin: 1 mg (n=42), 3 mg (n=55) or placebo (n=56) daily subcutaneously for 48 weeks. At the end of the study, a second biopsy was performed on 132 patients (86%) and was compared with the baseline liver biopsy.
Results of Adalfermin use
It was found that in 23% and 21% of patients with cirrhosis treated with aldafermin, the degree of fibrosis decreased by at least 1 stage, that is, they no longer had liver cirrhosis. Liver parameters (transaminases) also improved in patients treated with aldafermin compared to those who received placebo. The treatment was observed to produce some gastrointestinal side effects (diarrhea in 26-40% of patients; nausea in 29-33%), headache (10-15%) and fatigue (14-13%).
In the opinion of the Foundation’s team of hepatologists and Dr. Carreño, this study has been carried out with great rigor since two liver biopsies have been performed (baseline and final). Comparison of these biopsies has shown that with the drug aldafermin, liver cirrhosis can be reversed. In any case, these findings must be confirmed by studying a larger number of patients.