NCT04365868

Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

A Seamless, Adaptive, Phase 2b/3, 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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Galectin Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

Conditions

• Prevention of Esophageal Varices
• NASH - Nonalcoholic Steatohepatitis
• Cirrhosis

Interventions

Type	Name	Description
DRUG	belapectin	intravenous
DRUG	Placebo	intravenous

Timeline

• Start date: 2020-06-25
• Primary completion: 2025-03-11
• Completion: 2025-04-10
• First posted: 2020-04-28
• Last updated: 2026-02-20

Locations

156 sites across 15 countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany, Israel, Mexico, Poland, Puerto Rico, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study