GalMed Medical Research, a leader in research and development of products for the treatment of chronic lipid and liver related diseases, has initiated the multi-centre phase-II clinical trial with its proprietary, patented compound Aramchol for the treatment of conditions of Nonalcoholic fatty liver disease (NAFLD)and  nonalcoholic steatohepatitis (NASH). The company has previously completed phase-I studies in healthy volunteers, which successfully confirmed the good safety and pharmacokinetic profile of Aramchol.

The trial is to be conducted at eleven academic departments of Hepatology in Israel. The institutions that will participate in the phase-IIA double blind, randomized, placebo controlled study include: Tel-Aviv Sourasky Medical Center, Beilinson Hospital, Meir Medical Center, Kaplan Hospital, Soroka Hospital, Hadassah Medical Organization, Hillel Yaffe Medical Center, Rambam Hospital, The Lady Davis Carmel Medical Center, Holy Family Hospital and Ziv Hospital. The chief investigator for the trial is Professor Ran Oren, chair of the Liver & Gastroenterology Department at The Tel Aviv Sourasky Medical Center, Tel-Aviv University.

Professor Tuvia Gilat, CEO of GalMed commented, "Based on previous experimental studies as well as on recent phase I clinical results with Aramchol, we have reason to believe this drug will be an important new option in the treatment of patients with NAFLD and NASH. This phase II study will provide additional valuable insight into the potential benefits of Aramchol for the therapeutic management of these very chronic diseases related to lipid disorders and will hopefully confirm its safety profile also in patients.”

The study is designed to compare the changes in the concentration of liver triglycerides in patients treated with Aramchol versus placebo. Secondarily the study will be comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the patients treated with Aramchol and the those patients receiving the placebo.

Nonalcoholic fatty liver disease (NAFLD) refers to a wide spectrum of liver disease ranging from simple fatty liver (steatosis), to nonalcoholic steatohepatitis (NASH), to cirrhosis (irreversible, advanced scarring of the liver). All of the stages of NAFLD have in common the accumulation of fat (fatty infiltration) in the liver cells (hepatocytes). In NASH, the fat accumulation is associated with varying degrees of inflammation (hepatitis) and scarring (fibrosis) of the liver.