THE CLINICAL TRIAL
The Sponsor is a biopharma focused on the innovative treatments for cardio-metabolic diseases, such as nonalcoholic steatohepatitis (NASH). NASH is a progression of one of the most common liver diseases, nonalcoholic fatty liver disease (NAFLD). There are currently no pharmaceutical treatments for NASH. The ENliven Study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability in adults with NASH.
THE PROJECT
NASH is a progressive liver disease that occurs when fat accumulates in the liver and causes inflammation and scarring (fibrosis). If left untreated, it can lead to permanent liver damage (cirrhosis), liver failure, liver cancer or even the need for a liver transplant. About 3–5% of adults worldwide have NASH, but some studies suggest that number could be as high as 14%. Much of the strategy for this clinical trial was focused around providing education and awareness about this disease.