Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
← catalyst calendarSponsored by Galectin Therapeutics Inc. (industry) · GALT — their whole pipeline →.
Phase
Phase 2/3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
357actual
Sites
156
Countries
Argentina, Australia, Belgium +12
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-25 | actual | When the study began enrolling |
| Primary completion | 2025-03-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-10 | actual | The whole study's end, after follow-up |
| First posted | 2020-04-28 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Prevention of Esophageal Varices
- NASH - Nonalcoholic Steatohepatitis
- Cirrhosis
Interventions
- Drug: belapectin — also filed as GR-MD-02, galactoarabino rhamnogalacturonate
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo
measured At 78 weeks [18 months]
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-08-09 · 14.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-13 · 2.5 MB · SAP_001.pdf
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