This study is for men and women who have been diagnosed with liver cirrhosis due to Nonalcoholic Steatohepatitis (NASH). This study will test the following experimental/investigational drugs: an injectable named semaglutide and a fixed-dose combination tablet named cilofexor/firsocostat (CILO/FIR) for NASH.
The investigational drug CILO/FIR has not been approved for the treatment of NASH by the U.S Food and Drug Administration (FDA). Semaglutide is currently approved by the FDA for the treatment of Type 2 Diabetes, but not to treat NASH.
NASH is a more severe form of nonalcoholic fatty liver disease (NAFLD) in which the liver becomes fatty, inflamed and liver cells become injured. Over time, scar tissue (fibrosis) forms in the liver. When enough scarring is present, the liver is considered cirrhotic. A cirrhotic liver is unable to perform its normal functions and is at risk for failing.
Participants will be randomized into one of four study groups. Randomization is like flipping a coin and there is an equal chance of being assigned to each group.
The four groups will receive the following:
The placebo tablet will look like CILO/FIR tablet or semaglutide but will not contain active medicine/ingredients.
Taking part in this study will last approximately 77 weeks, which includes 72 weeks of taking the study drug(s) and a 5-week follow-up period. Participants will be compensated for their time.
Detailed eligibility reviewed when you contact the study team.