Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02)
Research type
Research Study
Full title
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.
IRAS ID
285344
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Galectin Therapeutics Inc.
Eudract number
2019-001983-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 115459
Duration of Study in the UK
5 years, 1 months, 12 days
Research summary
As there are no current treatments for NASH/NAFLD, the purpose of this study is to find out about the safety and effectiveness of Belapectin (GR-MD-002) for the prevention of esophageal varices (enlarged veins) in NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis (the origin and development of the disease) of fatty liver disease and fibrosis. The drug binds to galectin and disrupts its function. Pre-clinical data in animal studies have shown that Belapectin has robust treatment effects reversing liver fibrosis and cirrhosis. When studied in clinical trials in participants with NASH cirrhosis it showed some evidence of potentially reducing blood pressure in vessels entering cirrhotic liver and preventing the development of new esophageal varices.
Approximately 525 participants will take part in approximately 130 different institutions worldwide, conducted in 2 sequential stages.
Stage 1 (Phase 2b) will include approximately 315 participants and will consist of a screening period (approx 2 months) and a study treatment period during which treatment will be administered by intravenous infusion (IV) every other week for approximately 18 months (approxt 40 infusions).
Stage 2 (Phase 3) will include the participants that completed Stage 1 and additional 210 new participants. Stage 2 will consist of a study treatment administered by intravenous infusion every other week for approximately 18 months (about 40 infusions).
The entire study will be of approximately 39 months (3 years, 3 months).
Participants will have an equal chance of being randomly assigned to get one of the following treatments starting at Stage 1:
• Treatment 1: Belapectin (GR-MD-02) in a dose of 2mg/Kg Lean Body Mass (LBM)
• Treatment 2: Belapectin (GR-MD-02) in a dose of 4mg/Kg LBM
• Treatment 3: Placebo (looks like the study drug but does not have any active substance in)
Participants that completed Stage 1 treatment will continue into Stage 2 in the same treatment assigned.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0982
Date of REC Opinion
2 Nov 2020
REC opinion
Further Information Favourable Opinion