Belapectin for NASH Cirrhosis
(NAVIGATE Trial)

Recruiting in Palo Alto (17 mi)

+157 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Galectin Therapeutics Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing belapectin, a medication aimed at helping people with a severe liver condition called NASH cirrhosis. The study focuses on patients who have high blood pressure in their liver but no swollen veins in their esophagus. Belapectin works by reducing liver inflammation and scarring, which can improve liver function and reduce health problems.

Research Team

Pol Boudes, M.D.

Principal Investigator

Galectin Therapeutics Inc.

Eligibility Criteria

Adults aged 18-75 with NASH cirrhosis and signs of portal hypertension but no esophageal varices. They must have certain liver stiffness, blood work results, and agree to use contraception if fertile. Excluded are those with recent drug abuse, certain other liver diseases, major surgery or organ transplants within specific time frames.

Inclusion Criteria

I have abnormal blood vessels in my abdomen confirmed by a scan or physical exam.

My liver biopsy shows cirrhosis caused by fatty liver disease, with no other cause.

I have a liver condition with cirrhosis and no other liver disease causes, plus obesity, high blood pressure, diabetes, or abnormal blood fats.

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Exclusion Criteria

You have liver disease that is not caused by NASH.

My kidney function is reduced, with a filtration rate under 45 mL/min.

You have taken part in a new drug research study within the past 30 days or 5 half-lives, whichever is longer.

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Treatment Details

Interventions

Belapectin (Galectin Inhibitor)

Trial OverviewThe trial is testing the effectiveness and safety of Belapectin against a placebo in preventing esophageal varices in patients with NASH cirrhosis. It's a two-stage study where participants are randomly assigned to receive either Belapectin or a placebo.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: belapectin 4 mg/kg lean body mass (LBM)Experimental Treatment1 Intervention

Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose

Group II: belapectin 2 mg/kg lean body mass (LBM)Experimental Treatment1 Intervention

Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose

Group III: PlaceboPlacebo Group1 Intervention

Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)