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Study on Belapectin for Preventing Esophageal Varices in Patients with NASH Cirrhosis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as esophageal varices, which can occur in people with NASH cirrhosis. NASH stands for Non-Alcoholic Steatohepatitis, a type of liver disease that can lead to cirrhosis, or severe liver scarring. The study is testing a treatment called Belapectin, also known by its code name GR-MD-02. Belapectin is given as a solution for injection and is being compared to a placebo to see if it can help prevent the development of esophageal varices in people with NASH cirrhosis.

The purpose of the study is to evaluate how effective and safe Belapectin is in preventing esophageal varices. Participants in the study will receive either Belapectin or a placebo. The study will last for about 18 months, during which time participants will receive regular injections and have their health monitored closely. The study aims to see if Belapectin can reduce the number of people who develop esophageal varices compared to those who receive a placebo.

Throughout the study, researchers will also look at other health outcomes, such as whether participants develop other complications related to liver disease, like variceal bleeding or ascites, which is fluid buildup in the abdomen. The study will help determine if Belapectin can be a beneficial treatment for people with NASH cirrhosis to prevent these serious complications.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the investigational medication belapectin or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The patient will receive belapectin or placebo through an intravenous injection. The dosage of belapectin will be either 2 mg/kg or 4 mg/kg based on lean body mass. The frequency and duration of administration will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular monitoring to assess the development of esophageal varices. This includes medical examinations and possibly imaging tests to evaluate the condition of the liver and the presence of varices.

  4. Step 4

    Primary evaluation

    The primary goal is to determine the proportion of patients who develop esophageal varices after 78 weeks (approximately 18 months) of treatment with belapectin compared to placebo.

  5. Step 5

    Secondary evaluation

    Secondary outcomes include the incidence of complications such as variceal bleeding, ascites, bacterial infections, hepatic encephalopathy, and the need for liver transplantation. Mortality rates and changes in liver disease severity scores will also be monitored.

  6. Step 6

    Completion of the study

    The study is expected to conclude by January 14, 2028. At the end of the study, the data collected will be analyzed to determine the efficacy and safety of belapectin in preventing esophageal varices in patients with NASH cirrhosis.

Who can join the trial?

19 criteria

  • Must be a male or female between 18 and 75 years old.
  • If capable of having children, must agree to use two effective methods of birth control, one of which must be a physical barrier like a condom.
  • If a woman is breastfeeding, she must agree to stop nursing before starting the study and for 90 days after the last dose of the study treatment.
  • If a man, must agree not to donate sperm during the study and for 90 days after the last dose of the study treatment. If a woman, must not start any egg donation or harvesting during the study and for 90 days after the last dose of the study treatment.
  • Must be willing and able to sign a written consent form to participate in the study.
  • Must have signs of **portal hypertension**, which is high blood pressure in the vein that carries blood to the liver. This can be shown by one of the following:
    • A platelet count less than 150,000 per mm3.
    • A **HVPG measurement** greater than 6 mmHg, which is a test that measures pressure in the liver.
    • At least two of the following: a spleen size of 14 cm or more, visible blood vessels in the abdomen, a liver stiffness measurement of 20 kPa or more, or a ratio of AST/ALT greater than 1 (these are liver enzymes).
    • Must have a history of **NASH cirrhosis**, which is a type of liver disease, confirmed by one of the following:
      • A past liver biopsy showing cirrhosis with **steatohepatitis** (a type of liver inflammation).
      • A past liver biopsy showing steatohepatitis and evidence of cirrhosis from other tests or a second biopsy.
      • A past liver biopsy showing cirrhosis with **steatosis** (fat in the liver) but not steatohepatitis.
      • A past liver biopsy showing steatosis but now with cirrhosis confirmed by other tests.
      • Current or past imaging showing steatosis with cirrhosis.
      • If none of the above, a new liver biopsy is needed.
      • Must not have **HCC**, which is a type of liver cancer, confirmed by imaging within 6 months before joining the study.
      • If having type 2 diabetes, must be well-controlled on stable diabetes medication for at least 3 months before the study, with a blood sugar level (HbA1c) of 9.5% or less.
      • If taking vitamin E or **pioglitazone** (a diabetes medication), must have been on a stable dose for at least 3 months before the study, and the dose should remain the same during the study.
      • If taking a **statin** (a cholesterol-lowering medication), must have been on a stable dose for at least 3 months before the study, and the dose should remain the same during the study.
      • Must not be pregnant and must have a negative pregnancy test before joining the study.

Who cannot join the trial?

10 criteria

  • Patients who have a history of **esophageal varices**. These are swollen veins in the esophagus, which is the tube that carries food from the mouth to the stomach.
  • Patients with **NASH cirrhosis**. This is a liver condition where the liver becomes scarred due to fat buildup, not related to alcohol use.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of substance abuse or alcohol dependency.
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Investigated drugs

Belapectin (GR MD-02) is a medication being studied for its potential to prevent the development of esophageal varices in patients with NASH cirrhosis. Esophageal varices are enlarged veins in the esophagus that can cause serious bleeding. This medication is being tested to see if it can help stop these veins from forming, which could reduce the risk of bleeding and other complications in people with liver disease.

What is already known about the treatment

Belapectin – This medication is administered intravenously and is currently being studied in clinical trials for its potential to prevent esophageal varices in patients with NASH cirrhosis. It is in the phase 2b/3 stage of clinical trials, indicating that it is being evaluated for both efficacy and safety. The main therapeutic indication is the prevention of esophageal varices, which are enlarged veins in the esophagus that can occur in liver disease. Belapectin works by targeting galectin-3, a protein involved in inflammation and fibrosis, thereby potentially reducing liver scarring and associated complications. It is classified as an anti-fibrotic agent.

Investigated diseases

Esophageal Varices in NASH Cirrhosis – Esophageal varices are enlarged veins in the esophagus, which can occur due to increased pressure in the portal vein, often seen in cirrhosis. In the context of NASH (Non-Alcoholic Steatohepatitis) cirrhosis, the liver becomes scarred and damaged due to fat accumulation and inflammation, leading to increased portal pressure. As the disease progresses, these varices can become more pronounced and are at risk of bleeding. The development of esophageal varices is a significant complication in patients with cirrhosis, as it indicates advanced liver disease. Monitoring and managing these varices are crucial to prevent serious complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-512619-28-00Protocol codeGT-031Estimated enrolment357 patientsSponsorGalectin Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).