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NCT04365868 (Belapectin in Cirrhotic Portal Hypertension Caused by Metabolic…): BVCT ex-ante prediction vs. reported outcome

On 10 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 20 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04365868
Acronym
NAVIGATE
Drug Name
Belapectin
Drug MoA
galectin-3 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Human Patients
357
Sponsor
Galectin Therapeutics
Phase
Phase 2 Phase 3

Prediction of , index 1744

Prospective Prediction
Prediction Index
1744
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in esophageal varices prevention inferior to beta blockers)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in esophageal varices prevention)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
132 days in advance
Readout Data Interpretation
belapectin failed to achieve statistical significance in the primary endpoint of esophageal varices compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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
Phase
Phase 2, Phase 3
Status
Terminated
Enrollment
357
Lead sponsor
Galectin Therapeutics Inc.
Conditions
Prevention of Esophageal Varices; NASH - Nonalcoholic Steatohepatitis; Cirrhosis
Interventions
DRUG: belapectin; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Prevention
Start
2020-06-25
Primary completion
2025-03-11
Completion
2025-04-10
Results first posted
2026-06-30
Primary outcomes
  • Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo (At 78 weeks [18 months])

NCT04365868 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials