Recruiting

Study of Namodenoson Treatment in Patients with Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on Non-Alcoholic Steatohepatitis (also known as NASH), a liver condition where fat accumulates in the liver along with inflammation and damage. The study will test a medication called Namodenoson (also known as CF102), which is taken as a capsule by mouth. Some participants will receive the actual medication while others will receive a placebo.

The purpose of this research is to determine if Namodenoson can improve the condition of patients with NASH who have mild to moderate scarring of the liver (fibrosis). The medication being studied is a synthetic substance that works by interacting with specific receptors in the body called adenosine A3 receptors.

The study will last 36 weeks, during which participants will take either Namodenoson capsules or placebo capsules daily. Throughout the study, participants will have their liver health monitored through various medical examinations. The maximum daily dose of Namodenoson that participants may receive is 50 mg. The study is designed to evaluate both how well the medication works and how safe it is for patients with NASH.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
A medical evaluation will confirm if you have Non-Alcoholic Steatohepatitis (NASH) with liver fibrosis stage 1-3
A liver biopsy will be performed to confirm your diagnosis, unless you have had one within the past 6 months
Laboratory tests will check your liver function, blood cell counts, and kidney function
Step 2
Treatment assignment
You will be randomly assigned to receive either namodenoson capsules or placebo capsules
Neither you nor your doctor will know which treatment you are receiving
The medication or placebo will be taken by mouth
Step 3
Treatment period
The treatment period will last 36 weeks
Regular check-ups will monitor your health status
Blood tests will track changes in your liver function
You must maintain any existing stable treatments for other conditions
Step 4
Final evaluation
At week 36, a second liver biopsy will be performed
The results will determine if there has been an improvement in your liver condition
Your liver enzyme levels will be compared to the start of the study
The study will evaluate if the treatment improved your NASH by at least 2 points on a specialized scoring system

Who can join the trial?

19 criteria

Must be at least 18 years old
Must agree to have 2 liver biopsies (a procedure where a small sample of liver tissue is taken for examination)
Must be willing to attend all scheduled visits, follow treatment plans, and complete required laboratory tests
Must have an AST level (a liver enzyme) of 20 IU/L or higher at screening
Must have confirmed NASH diagnosis through liver biopsy with a score of at least 4 on the NAFLD activity score, including evidence of fat accumulation, inflammation, and liver cell damage
Must have liver scarring (fibrosis) at stage 1-3
Must have at least 2 of these metabolic conditions:
- Increased waist size (more than 88 cm for women or 102 cm for men)
- High triglycerides (blood fats) above 150 mg/dL
- Low HDL cholesterol (less than 40 mg/dL in men or 50 mg/dL in women)
- Controlled high blood pressure
- High fasting blood sugar (100 mg/dL or higher)
- Must have good liver function shown by:
  - Blood albumin level of 3.5 gm/dL or higher
  - Blood clotting test (INR) of 1.3 or less
  - Total bilirubin of 2.0 mg/dL or less
  - Must have acceptable blood test results showing:
    
    Adequate white blood cell count
    Platelet count of 150 x 109/L or higher
    Kidney function (eGFR) of 50 mL/min/1.73m2 or higher
    If taking herbal supplements or alternative treatments, must have been on a stable dose for at least 3 months
    Must be able to understand and sign informed consent documents

Who cannot join the trial?

15 criteria

History of significant alcohol consumption (more than 2 drinks per day for women and 3 drinks per day for men)
Presence of other types of liver disease (such as viral hepatitis, autoimmune hepatitis, or drug-induced liver injury)
Advanced liver scarring (cirrhosis) or end-stage liver disease
Pregnancy or breastfeeding
Active cancer or cancer treatment within the past 5 years
Uncontrolled diabetes (blood sugar that is not well managed)
Severe heart, kidney, or lung disease
Use of medications that can affect the liver or interact with the study drug
Participation in another clinical trial within the past 30 days
History of poor compliance with medical treatments
Mental health conditions that could interfere with study participation
Inability to provide informed consent
Drug or substance abuse within the past 6 months
Body Mass Index (BMI) greater than 45
Any condition that, in the investigator's opinion, makes the patient unsuitable for the study

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD
Verified
Sofia, Bulgaria
Centrul Medical Dr. Ianosi
Verified
Craiova, Romania
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Namodenoson is a medication being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH), a severe form of fatty liver disease. This medication is designed to help reduce liver inflammation and improve liver health in patients who have accumulated excess fat in their liver not caused by alcohol consumption. It works by targeting specific receptors that may help decrease liver inflammation and reduce liver damage.

Namodenoson

What is already known about the treatment

Namodenoson - An investigational drug administered orally that is currently being studied in Phase 2B clinical trials for the treatment of Non-Alcoholic Steatohepatitis (NASH) with liver fibrosis. This medication belongs to the class of selective A3 adenosine receptor agonists and works by targeting specific cellular pathways involved in reducing liver inflammation and fat accumulation. The drug is being evaluated for its ability to improve NASH symptoms and reduce liver damage, as measured by the NAFLD activity score, with ongoing research focused on establishing its safety and efficacy profile in patients with NASH who have varying degrees of liver fibrosis.

Investigated diseases

Non-Alcoholic Steatohepatitis (NASH) - A progressive liver condition characterized by fat accumulation in the liver, accompanied by inflammation and cell damage. NASH develops when excess fat builds up in liver cells, leading to swelling and damage over time. The condition can cause scarring (fibrosis) of liver tissue, with severity ranging from mild (F1) to advanced (F3) stages. This disease is not caused by alcohol consumption but rather by metabolic factors and can occur alongside conditions like obesity or diabetes. The liver may become enlarged and less efficient at performing its normal functions as the disease progresses.