Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis

In brief

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

Key facts

Study ID

NCT04365868

Run by

Galectin Therapeutics Inc.

People needed

357

Starts

2020-06-25

Expected to finish

2025-04-10

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each subject must meet all of the following criteria to be enrolled in this study:
• Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.
• Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
• Has evidence of portal hypertension, with either one of the following:
• platelet count <150,000/mm3
• OR
• documented hepatic venous pressure gradient (HVPG) measurement >6 mmHg
• OR
• at least two of the following:
• spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan)
• abdominal collateral circulation (documented by ultrasound, MRI, or CT scan or physical examination, ie, caput medusae)
• documented liver transient elastography (eg, FibroScan) ≥20 kilopascals (kPa).
• aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >1.
• Has a history confirming nonalcoholic steatohepatitis (NASH) cirrhosis, with at least one of the following:
• There is a historical liver biopsy showing cirrhosis with steatohepatitis. There is no evidence for a competing etiology for the cirrhosis.
• There is a historical liver biopsy showing steatohepatitis, and there is evidence of cirrhosis from clinical or imaging data or a second liver biopsy showing cirrhosis without all features of NASH (as the histological NASH lesions may have burnt out). There is no evidence for a competing etiology. There is at least 1 co-existing metabolic comorbidity at Screening: obesity (with either body mass index [BMI] ≥30 kg/m2 or waist circumference ≥102 cm [40 in, men] or ≥88 cm [35 in, women], or by ethnically appropriate cutpoints); hypertension (either on anti hypertensive drug therapy for at least 1 year or systolic/diastolic blood pressure (BP) >140/80 mm Hg); Type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%, or on anti-diabetic medication for at least 1 year); or dyslipidemia (triglycerides ≥150 mg/dL or on drug therapy for hypertriglyceridemia for at least 6 months; high-density lipoprotein cholesterol ≤40 mg/dL [men] or ≤50 mg/dL [women]) to corroborate a diagnosis of nonalcoholic fatty liver disease (NAFLD).
• There is a historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis. There is no evidence for a competing etiology. There are at least 2 co-existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
• There is a historical liver biopsy showing steatosis but now with cirrhosis either by clinical examination, imaging, or biopsy. If there is a current biopsy, it does not show evidence of steatosis or steatohepatitis as histological lesions may have burned out. There is no evidence for a competing etiology. There are at least 2 co existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
• Patient with cirrhosis with current or previous imaging showing steatosis. There is no liver histology available. There is no evidence for a competing etiology. There are at least two co-existing or history of metabolic comorbidities with obesity or diabetes being one of them to corroborate a diagnosis of NAFLD.
• For patients not meeting the above mentioned criteria, a screening liver biopsy is necessary.
• Note: All liver biopsy blocks and/or slides for eligibility assessments (including those from historical biopsies) will be reviewed by the central study pathologist while the subject is in Screening. Results from the central study pathologist must be available before the subject is randomized.
• Absence of hepatocellular carcinoma (HCC) by valid imaging (eg, ultrasound, CT scan, or MRI) within 6 months prior to randomization. If no such imaging result is available, then ultrasound imaging should be performed as part of standard of care.
• Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is ≤9.5%.
• Patients on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial.
• Patients on a statin can be enrolled if they are on a stable regimen for at least 3 months before Screening, and expected to be held stable during the trial.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening. Patients with portal hypertensive gastropathy could be enrolled.
• History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous bacterial peritonitis or overt hepatic encephalopathy (West Haven grade ≥2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening.
• Known or suspected abuse of alcohol (>20 g/day for women or >30 g/day for men [on average per day]), as per medical history. Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males. On average, a standard drink in the United States is considered to be 14 grams of alcohol, equivalent to 12 fluid ounces of regular beer (5% alcohol), 5 fluid ounces of table wine (12% alcohol), or 1.5 fluid ounces of 80 proof spirits (40% alcohol).
• Alcohol dependence (ie, a score >8 on the Alcohol Use Disorders Identification Test)
• Narcotics or any other drug abuse or dependence in the last 5 years
• Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
• Documented causes of liver disease other than NASH, including but not restricted to:
• Viral hepatitis, unless eradicated at least 3 years prior to Screening
• acute hepatitis A infection (presence of hepatitis A immunoglobulin M [IgM] at Screening)
• positive hepatitis B surface antigen
• positive hepatitis C virus (HCV) ribonucleic acid (to be performed prior to randomization in case of positive HCV antibody)
• Documented drug-induced liver disease
• Alcoholic liver disease
• Autoimmune hepatitis
• Wilson's disease
• Hemochromatosis
• Primary biliary cholangitis
• Primary sclerosing cholangitis
• Genetic hemochromatosis
• History or planned liver transplantation
• Alpha-1 antitrypsin deficiency
• History of human immunodeficiency virus (HIV), or positive HIV test at Screening
• Any of the following test or score:
• serum alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN)*

Where it is running

• Digestive Health Specialists — Dothan, Alabama, United States
• The Institute for Liver Health — Chandler, Arizona, United States
• Arizona Liver Health - Glendale — Glendale, Arizona, United States
• Institute for Liver Health - Tucson — Tucson, Arizona, United States
• Liver Wellness Center - Little Rock — Little Rock, Arkansas, United States
• Hope Clinical Research, Inc. — Canoga Park, California, United States
• Southern California GI & Liver Centers — Coronado, California, United States
• University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices — La Jolla, California, United States
• Om Research LLC — Lancaster, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• inSite Digestive Health Care - Orange — Orange, California, United States
• California Liver Research Institute — Pasadena, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Integrity Clinical Research, LLC (ICR SITES) - Doral — Doral, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Mayo Clinic Hospital - Florida — Jacksonville, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• ClinCloud LLC — Maitland, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Genoma Research Group, Inc. — Miami, Florida, United States
• Sensible Healthcare — Ocoee, Florida, United States
• Guardian Angel Health Services, Inc. — Tampa, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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