What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis include diuretics, beta-blockers, and medications like tolvaptan. Known side effects of these treatments can include increased liver enzymes, chest pain, headache, hyperuricemia, and electrolyte imbalances such as hypernatremia. Specifically, tolvaptan has been associated with increased serum alanine transaminase levels and hyperuricemia. For treatments similar to Belapectin, which is a Galectin-3 inhibitor, side effects are not well-documented, but general side effects for liver cirrhosis treatments can include gastrointestinal disturbances, fatigue, and potential liver function abnormalities.

What prior FDA approvals exist?

FDA-approved treatments for liver cirrhosis primarily focus on managing symptoms and complications rather than reversing the condition. Ursodeoxycholic acid (UDCA) is approved for primary biliary cirrhosis, helping to improve liver function and delay disease progression. Obeticholic acid is another approved drug for primary biliary cholangitis, a type of cirrhosis. While Belapectin, a Galectin-3 inhibitor, is still under investigation, it represents a novel approach targeting fibrosis and inflammation pathways. Currently, no Galectin-3 inhibitors have received FDA approval for liver cirrhosis.

What other types of research exist?

Promising novel alternatives to Belapectin for liver cirrhosis patients in 2024 include: 1) Tolvaptan, a vasopressin V2 receptor antagonist, which has shown efficacy in managing ascites in cirrhotic patients. 2) Vaptans, which have been studied for their impact on clinical outcomes in cirrhosis patients with ascites and/or hyponatremia. 3) Antiviral therapies such as Entecavir and Tenofovir for hepatitis B-related cirrhosis, which have demonstrated long-term benefits in viral suppression and histological improvement. 4) Combination therapies like Atezolizumab plus Bevacizumab for advanced hepatocellular carcinoma, which may benefit cirrhosis patients with concurrent liver cancer.

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Galectin Inhibitor

Belapectin for NASH Cirrhosis (NAVIGATE Trial)

Verified Trial

Phase 2 & 3

Waitlist Available

Research Sponsored by Galectin Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.

spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan)

Must not have

Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening

History of hepatic cirrhosis decompensation or develops signs of hepatic cirrhosis decompensation during Screening

Timeline

Screening 10 weeks

Treatment 156 weeks

Follow Up at 78 weeks [18 months]

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While the side effects for Belapectin aren't specified here, typical medication risks may include allergic reactions, gastrointestinal issues like nausea or diarrhea, fatigue, headaches, and potential liver-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My spleen is larger than 14 cm as shown by an imaging test.

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

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

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have varices in my esophagus or stomach confirmed by an upper GI exam.

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I have or developed signs of worsening liver cirrhosis.

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I have had a procedure to connect two veins in my liver.

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I have had or am planning to have a liver transplant.

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I have Alpha-1 antitrypsin deficiency.

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I have HIV or tested positive for HIV.

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

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I have had major surgery recently.

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I have had an organ transplant and am on immunosuppressive drugs.

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I had weight loss surgery within the last year or plan to during the study.

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I haven't had cancer in the last 5 years, except for skin or treated cervical cancer.

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I have serious heart or blood vessel problems.

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I have received belapectin treatment within the last 6 months.

Timeline

Screening ~ 10 weeks2 visits

Treatment ~ 156 weeks80 visits

Follow Up ~ at 78 weeks [18 months]

Screening ~ 10 weeks

Treatment ~ 156 weeks

Follow Up ~at 78 weeks [18 months]

This trial's timeline: 10 weeks for screening, 156 weeks for treatment, and at 78 weeks [18 months] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo

Secondary study objectives

Efficacy: Cumulative incidence rate of patients in the belapectin Phase 3 treatment group who progress to large varices (gastric or esophageal) or develop red wales compared to placebo.

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)

+15 more

Other study objectives

Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3

Exploratory Efficacy:Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3

Safety: Incidence of adverse events

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

belapectin

2020

Completed Phase 1

~40

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cirrhosis include medications like ursodeoxycholic acid, which reduces bile acid toxicity, and antiviral therapies for viral hepatitis, which target the underlying cause of liver damage. Belapectin, a Galectin-3 inhibitor, is being studied for its potential to prevent esophageal varices by reducing fibrosis and inflammation in the liver. These treatments are crucial for liver cirrhosis patients as they aim to slow disease progression, manage symptoms, and prevent complications such as portal hypertension and variceal bleeding, thereby improving quality of life and survival rates.

Treatment for hepatorenal syndrome in people with decompensated liver cirrhosis: a network meta-analysis.Novel treatment options for portal hypertension.Correction of hyponatraemia improves cognition, quality of life, and brain oedema in cirrhosis.