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Research & Development

Basic Research and Clinical Data

Clinical Data

Aramchol’s safety profile has been established in both a Phase I and a Phase IIa study. The Phase I trials (single and repeated) evaluated 41 healthy male volunteers. The trial results showed no notable changes in biochemical, hematological, cardiovascular or other safety parameters.

In addition, Galmed has also completed a Phase IIa study, which included 60 NAFLD and NASH patients (ages 18-65) who were treated for 3 month, with an additional one-month follow-up period. The trial was designed as a double blind, randomized, placebo controlled study.

Aramchol treatment demonstrated a significant reduction liver fat content in a dose-dependent manner. Additionally, biochemical markers for liver inflammation and metabolic indexes, including ALT, adiponectin, HOMA and endothelial function, also established trends of improvement during treatment.

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During the 3-month treatment period and subsequent recovery period, no severe drug related adverse events were observed.

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