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Study of Dasatinib and Quercetin combination for treating liver fibrosis in patients with Non-Alcoholic Fatty Liver Disease (NAFLD)

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What is this trial about?

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

This study focuses on Non-alcoholic Fatty Liver Disease (NAFLD), a condition where excess fat builds up in the liver of people who drink little or no alcohol. The study will test a combination of two medications: dasatinib and quercetin. These medications belong to a class called senolytics, which work by removing aging cells that may contribute to liver damage.

The purpose of this research is to determine if the combination of dasatinib and quercetin can improve liver scarring (also known as liver fibrosis) in people with NAFLD. The treatment will last for 21 weeks, during which participants will receive either the combination of these medications or placebo in the form of oral tablets.

During the study, doctors will monitor the condition of participants' livers using various tests, including examining small samples of liver tissue. The treatment involves taking dasatinib up to 180 mg per day and quercetin up to 1000 mg per day. The study uses a double-blind design, which means neither the participants nor the doctors will know who receives which treatment until the study is complete.

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 treatment phase
You will begin taking two medications: dasatinib and quercetin. Both medications are taken by mouth.
The treatment period lasts for 21 weeks (approximately 5 months).
Step 2
Medical evaluations during treatment
Your liver health will be monitored through various tests, including:
Blood tests to check liver function, blood sugar levels, and other health indicators
Physical examinations and vital signs monitoring
FibroScan (a non-invasive test to measure liver stiffness)
Heart monitoring through pulse checks and ECG
Morning stool sample collection for analysis
Step 3
Quality of life assessment
You will complete questionnaires about your physical and mental health using standard forms (RAND-36 and EQ-5D-5L)
These forms help assess how the treatment affects your daily life and overall well-being
Step 4
Final evaluation
At week 21, you will undergo a liver biopsy to examine changes in your liver tissue
Final blood tests and health assessments will be conducted to compare with your initial results
The medical team will evaluate if your liver fibrosis has improved during the treatment period

Who can join the trial?

16 criteria

Age between 18 and 70 years old
Must have NAFLD (fatty liver disease) confirmed by non-invasive liver tests
Must agree to undergo a liver biopsy (a procedure where a small sample of liver tissue is taken) after treatment
Must have stable liver function with the following blood test results:
- Liver enzyme ALAT less than 10 times the upper normal limit
- Hemoglobin above 11g/dL for women and 12g/dL for men
- White blood cells above 2.5K/μL
- Neutrophils (type of white blood cells) above 1.5K/μL
- Platelets above 100K/μL
- Total bilirubin below 35 μmol/L
- Albumin above 30 g/L
- Normal blood clotting (TP above 80% or INR below 1.4)
- Normal kidney function (creatinine below 1.3 mg/dL for men or 1.1 mg/dL for women)
- Weight must be stable (no more than 5% weight loss from starting weight)
- For women who can become pregnant:
  - Must have a negative pregnancy test or be post-menopausal
  - Must use effective birth control methods
  - Must be able to provide informed consent (understand and agree to participate in the study)

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years
Presence of other types of liver disease besides MASLD/NAFLD (fatty liver disease)
Pregnancy or breastfeeding
Current or recent participation in other clinical trials
Severe liver damage (cirrhosis)
History of liver cancer
Uncontrolled high blood pressure
Severe heart, kidney, or lung disease
Active infections
Use of medications that could interact with the study drugs
Alcohol consumption exceeding 2 drinks per day for men or 1 drink per day for women
Inability to provide informed consent
History of allergic reactions to similar medications
Significant abnormalities in blood tests
Inability to undergo liver biopsy

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Responsive
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Dasatinib is a medication typically used in cancer treatment that belongs to a class of drugs called tyrosine kinase inhibitors. In this trial, it is being studied as a senolytic agent, which means it helps eliminate aging cells that may contribute to liver disease. Quercetin is a natural flavonoid compound found in many fruits and vegetables. When used as a medication, it acts as a senolytic agent and has antioxidant properties. In this trial, it is being combined with dasatinib to target aging cells that may be involved in liver fibrosis (scarring) associated with non-alcoholic fatty liver disease. The combination of dasatinib and quercetin is being tested to see if it can improve liver fibrosis in patients with non-alcoholic fatty liver disease (NAFLD). This combination therapy works by removing damaged cells that may be contributing to liver scarring.

What is already known about the treatment

Dasatinib
A targeted therapy medication taken orally that belongs to the class of tyrosine kinase inhibitors, specifically designed to eliminate senescent cells in liver tissue. This drug, commonly used in combination with quercetin for treating liver fibrosis in non-alcoholic fatty liver disease (NAFLD), works by blocking specific cellular signaling pathways that maintain senescent cells. Originally developed for treating certain types of leukemia, it is now being investigated for its senolytic properties in liver diseases, with clinical trials exploring its potential to improve liver fibrosis scores.
Quercetin
A natural flavonoid compound administered orally that belongs to the class of plant-derived antioxidants, commonly found in many fruits and vegetables. When used in combination with dasatinib, it acts as a senolytic agent, helping to eliminate aged or damaged cells that contribute to liver fibrosis in non-alcoholic fatty liver disease (NAFLD). This supplement works by promoting cell death in senescent cells while protecting healthy cells, and has shown promising results in clinical trials for liver disease treatment when combined with dasatinib.

Investigated diseases

MASLD (Metabolic Associated Steatotic Liver Disease)
A liver condition characterized by excessive fat accumulation in the liver cells, associated with metabolic risk factors such as obesity, diabetes, or high blood pressure. The disease can progress slowly over time, causing inflammation and scarring of liver tissue. The condition develops in people who drink little to no alcohol but have metabolic health issues.
NAFLD (Non-Alcoholic Fatty Liver Disease)
A broad term for a range of liver conditions affecting people who drink little to no alcohol, where excess fat is stored in liver cells. The condition begins with simple fatty liver, where fat accumulates in the liver cells. Over time, it may progress to cause inflammation and liver cell damage. The disease is closely linked to obesity, insulin resistance, and other metabolic health conditions.