This is a Phase 2b/3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of the study drug Belapectin (GR-MD-02) in men and women with non-alcoholic steatohepatitis (NASH) Cirrhosis (which is a scarring of the liver due to fatty liver disease and inflammation) and have not yet developed any complications of cirrhosis.   

The purpose of this study is to find out about the safety and efficacy of Belapectin for the prevention of esophageal varices (enlarged veins in the esophagus) in NASH Cirrhosis. Belapectin has been studied in clinical trials in participants with NASH cirrhosis and showed some evidence of potentially reducing the blood pressure in vessels entering cirrhotic liver and preventing the development of new esophageal varices.   

An investigational/experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for sale in the United States or by any regulatory authorities in any country in the world. Experimental drugs such as Belapectin may be tested in research studies such as this one.   

This study will be conducted in 2 sequential stages.
   

Stage 1 (Phase 2b) will consist of a screening period (about 2 months) and a study drug period during which study drug will be administered by intravenous (IV) infusion every other week for a period of approximately 18 months (about 40 infusions).   

Stage 2 (Phase 3) will include the participants that completed Stage 1 and additional 210 new participants. Similar to Stage 1, Stage 2 will consist of a study drug administered by intravenous infusion every other week for a period of approximately 18 months (about 40 infusions).
   

The complete study drug period will consist of approximately 36 months (about 80 infusions).   

Individuals who qualify for this study will have an equal chance of being randomly assigned (like the flip a coin) to one of the following study drug arms starting at Stage 1: 

• Study drug arm 1: Belapectin in a dose of 2mg/Kg Lean Body Mass (LBM)
• Study drug arm 2: Belapectin in a dose of 4mg/Kg LBM
• Study drug arm 3: Placebo (it looks like the study drug but does not have any active substance in it)
     

The placebo will look like Belapectin but will not contain active medicine/ingredients.
   
Belapectin and placebo will be supplied by Galectin Therapeutics, Inc. which is the sponsor of this study.
   
   Participation in this study will last about 39 months.
   
   Participants will be compensated for their time.