This clinical trial is focused on studying a liver condition called Nonalcoholic Steatohepatitis (NASH), which is a type of liver disease that occurs in people who drink little or no alcohol. It involves inflammation and damage to the liver, along with fat buildup. The study is specifically looking at patients with NASH who also have liver fibrosis, which means there is some scarring of the liver tissue. The trial will test the effectiveness and safety of a combination therapy using two medications: pemafibrate (also known by its code name K-877-ER) and tofogliflozin (also known by its code name CSG452). These medications are taken as tablets.
The purpose of the study is to evaluate whether the combination of these medications, or each one individually, is better than a placebo in improving liver health over a period of 48 weeks. Participants will be randomly assigned to receive either the combination therapy, one of the medications, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased.
Throughout the study, participants will have regular check-ups and tests to monitor their liver condition and overall health. The main goal is to see if there is an improvement in liver disease activity and no worsening of liver fibrosis after 48 weeks. The study will also look at other factors, such as the resolution of liver inflammation and fat buildup. Participants will be closely monitored to ensure their safety and well-being during the trial.



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