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Using namodenoson to treat non-alcoholic steatohepatitis

A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Phase 2 Interventional Can-Fite BioPharma · NCT04697810

This study is testing if a new oral medication called namodenoson can help people with non-alcoholic steatohepatitis (NASH) improve their liver health over 36 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment114 (estimated)
Ages18 Years and up
SexAll
SponsorCan-Fite BioPharma Industry-sponsored
Drugs / interventionsmethotrexate, prednisone
Locations24 sites (Banja Luka and 23 other locations)
Trial IDNCT04697810 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of namodenoson, administered orally at a dose of 25 mg every 12 hours, in patients diagnosed with non-alcoholic steatohepatitis (NASH) and varying degrees of fibrosis. Participants will be randomly assigned to receive either the drug or a placebo for 36 weeks, with regular assessments of safety and efficacy biomarkers. A liver biopsy will be performed at the end of the treatment period to assess the drug's impact on liver health. The study aims to gather data from approximately 114 subjects across multiple centers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with biopsy-proven NASH and specific fibrosis levels.

Not a fit: Patients with advanced liver disease or those who do not meet the metabolic syndrome criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and reduce the progression of NASH in affected patients.

How similar studies have performed: While there have been studies on NASH treatments, the specific approach using namodenoson is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. At least 18 years of age.
2. AST at Screening of ≥20 IU/L.
3. FibroScan LSM ≥8.5 kPa
4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.
5. Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).
6. At least 2 of the following criteria for the metabolic syndrome:

   * Obesity, defined waist circumference \>88 cm for women or \>102 cm for men
   * Hypertriglyceridemia, defined as \>150 mg/dL (\>1.7 mmol/L) or on drug treatment for hypertriglyceridemia
   * Reduced high-density lipoprotein (HDL) cholesterol, defined as \<40 mg/dL (\<1.03 mmol/L) in men or \<50 mg/dL (\<1.3 mmol/L) in women
   * History of hypertension, currently controlled in the judgment of the Investigator
   * Elevated fasting glucose, defined as ≥100 mg/dL (≥5.6 mmol/L).
7. Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:

   * Serum albumin ≥3.5 gm/dL
   * International normalized ratio ≤1.3
   * Serum total bilirubin ≤2.0 mg/dL (unless subject has known Gilbert's Syndrome).
8. The following laboratory values must be documented at Screening:

   * Absolute neutrophil count at least 1.0 x 109/L
   * Platelet count at least 150 x 109/L
   * Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2
9. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range.
10. Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after.
11. Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.
12. Understand and provide written informed consent to participate.
13. Willing to undergo 2 liver biopsies.
14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.

Exclusion Criteria:

1. Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.
3. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
4. Weight loss of \>5% within 3 months prior to Baseline.
5. History of bariatric surgery within 5 years of Screening.
6. Diabetes mellitus other than Type II.
7. Hemoglobin A1c \>9.0% (subjects with diabetes).
8. Any contraindication to percutaneous liver biopsy.
9. Daily alcohol intake \>20 g (2 units)/day for women and 30 g (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.
10. Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia \[sitagliptin\], Byetta \[incretin\], etc.), pioglitazone, or SGLT2 inhibitors ("gliflozin" drugs); unless the dose and regimen has been stable for at least 3 months.
11. Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.
12. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \>10 mg prednisone-equivalent concurrently or within 1 year.
13. More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.
14. Uncontrolled or clinically unstable thyroid disease.
15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.
16. Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.
17. QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \> 450 milliseconds (msec) for males or \> 470 msec for females.
18. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.
19. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.
20. Active gastrointestinal disease which could interfere with the absorption of oral medication.
21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.

Where this trial is running

Banja Luka and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NASH - Nonalcoholic Steatohepatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.