Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Condition: Nonalcoholic steatohepatitis (NASH), cirrhosis
Key Inclusion Criteria:
- 18-75 years old
- Evidence of portal hypertension
- History confirming nonalcoholic steatohepatitis (NASH) cirrhosis
Key Exclusion Criteria:
- Presence of esophageal, gastroesophageal, or isolated gastric varices
- History of hepatic cirrhosis decompensation
- Known or suspected abuse of alcohol
A Seamless, Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis - GT-031 NASH-RX (IRB no. 00000854)
This study focuses on individuals who may have nonalcoholic steatohepatitis (NASH) cirrhosis (scarring of the liver due to fatty liver disease and inflammation) and have not yet developed any complications of cirrhosis. The purpose of the study is to determine the safety and efficacy of an investigational drug called belapectin (GR-MD-02) for the prevention of esophageal varices (enlarged veins in the esophagus) in NASH cirrhosis.
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the origin and development of fatty liver disease and fibrosis. Belapectin binds to galectin and disrupts its function. Previous studies show some evidence of the drug potentially reducing the blood pressure in vessels entering the cirrhotic liver and preventing the development of new esophageal varices. The esophagus is a muscular tube connecting the throat with the stomach and carries food and liquids to the stomach. The development of esophageal varices is one of the complications of cirrhosis and can cause unexpected and often severe bleeding in the digestive system.