Fatty liver is a very common disease in Italy; this disorder affects “at least 20% of our population, and the main causes are overweight and obesity due to changes in our eating habits that resulted in diets rich in industrialized foods with a high level of calories and lipids”, explained Professor Alessio Aghemo, Head of the General Medicine and Hepatology Unit at Humanitas.

Fatty liver: the importance of weight loss and medical treatments

Nowadays, people suffering from fatty liver have to intervene primarily on weight loss, Aghemo explained, ” by increasing physical activity and some changes in the diet”.

Unfortunately, this type of measure leads to limited and often only temporary effects: for this reason it is fundamental to “develop more effective pharmacological treatments for this disease, also called non-alcoholic steatohepatitis or NASH“.

The studies in Humanitas on new drugs: Positive data on obeticolic acid

There are several ongoing studies on drugs for the treatment of fatty liver: for the moment the data and the evidence have been conflicting, with many drugs in development that still haven’t achieved the objectives set within research protocols. Finally, however, “positive data with obeticolic acid (OCA), a commercially available drug for primary biliary cholangitis (PBC) in prescribing centers such as Humanitas,” said Prof. Aghemo.

We also talked about it with Professor Ana LLeo de Nalda of the General Medicine and Hepatology Unit, responsible at Humanitas for the studies on this drug.

The first results of the Regenerate study will be presented at the European Congress of Hepatology in Vienna, this coming April. The research has involved 931 patients “with NASH, with stage 2 or 3 fibrosis, who were included in the study and randomized to OCA treatment with 10 mg, or OCA 25 mg or placebo,” explained the professor. “The interim analysis, after the first 18 months of treatment, showed a significant reduction in fibrosis in patients treated with OCA.

“Obeticolic acid is regularly used in our Center for patients with primary biliary cholangitis unresponsive to the first line of therapy and has an excellent safety profile: it is taken orally and is well tolerated by patients. The results of the Regenerate study seem to suggest treatment for patients with NASH for the first time,” concluded the professor.