NAFLDPhase 1/2NCT05506488
Dasatinib and Quercetin to Treat Fibrotic Non-alcoholic Fatty Liver Disease
A Phase 1/2 study testing Dasatinib 100 MG + Quercetin (1000 MG) in people with NAFLD and NASH With Fibrosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
To examine the effect of dasatinib plus quercetin on liver fibrosis in individuals with biopsy proven NAFLD with fibrosis by performing a double-blind randomized controlled proof-of-principle study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD, NASH With Fibrosis, Liver Fibrosis
- What is being tested?
- Dasatinib 100 MG + Quercetin (1000 MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jul 2023to 26 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult individuals, age > 18 years
- NAFLD with fibrosis score >2 according to the Steatosis Activity and Fibrosis score, but no cirrhosis histological diagnosis according to the SAF fibrosis score on a liver biopsy performed < 6 months before screening in the study and confirmed by central reading during the screening period.
- Individuals agrees to have a liver biopsy performed after the treatment
- Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol:
- ALAT <10x ULN
- Hemoglobin > 11g/dL for females and 12 g/dL for males
Show all 15Show fewer
- White blood cell (WBC) > 2.5 K/ μL
- Neutrophil count > 1.5 K μL
- Platelets > 100 K/μL
- Total bilirubin <35 μmol/L
- Albumin >30 g/L
- TP >80% or INR <1.4
- Serum creatinine <1.3 mg/dL (men) or <1.1 mg/dL (women) or estimated glomerular filtration rate (eGFR) > 60mL/min/1.73m2
- Have a stable weight since the liver biopsy was performed defined by no more than a 5% loss of initial body weight
- Subjects should be able to give informed consent
Who cannot join
- Evidence of another form of liver disease
- History of sustained excess alcohol ingestion: daily consumption >30g/day (3 drinks per day) for males and >20 g/day (2 drinks per day) for females
- Unstable metabolic condition: weight change > 5 kg in the last three months, diabetes with poor glycaemic control (HbA1c > 8.5%), introduction of an antidiabetic or of an anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the past 6 months prior to screening
- Bariatric surgery
- ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose oestrogens, methotrexate, tetracycline or amiodarone in the previous 6 months
- Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, active malignancy, compromised immunity
Show all 15Show fewer
- Pregnancy/lactation or inability to adhere to adequate contraception in woman of childbearing potential
- Body mass index (BMI) >45 kg/m2
- Type 1 diabetes
- Haemostasis disorders or current treatment with anticoagulants
- Contra-indication to liver biopsy
- History of/or current cardiac dysrhythmias and/or a history of cardiovascular disease event, including myocardial infarction, except patients with only well controlled hypertension
- QTc >450 msec on ECG
- Use of prescribed drugs dependent on CYP3A4 with narrow therapeutic window and strong inducers or inhibitors of CYP3A4
- Use of H2-antagonists and/or Proton Pump Inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dasatinib and Quercetin, a Combination of Senolytics to Treat Fibrotic Non-alcoholic Fatty Liver Disease - the TRUTH Study
To examine the effect of dasatinib plus quercetin on liver fibrosis in individuals with biopsy proven NAFLD with fibrosis by performing a double-blind randomized controlled proof-of-principle study
Read the detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is estimated to affect approximately 25-30% of the population in Western countries and is now the leading cause of chronic liver disease globally. NAFLD is a progressive liver disease and approximately 30% of individuals progress from simple steatosis to Non-Alcoholic Steatohepatitis (NASH), which can further progress to cirrhosis and hepatocellular carcinoma. In the Netherlands, it is estimated that 2.5 million people have NAFLD and this number is thought to increase by 50% in the next 10 years driven by an increasing prevalence of obesity and type 2 diabetes, and an ageing population. Independent of other cardiometabolic diseases, cardiovascular disease is the leading cause of death in individuals with NAFLD, followed by extrahepatic malignancies and liver-related complications. NAFLD results in sustained healthcare costs and economic losses, and reduced health-related quality of life.
It is now widely accepted that liver fibrosis is a result of liver injury secondary to NAFLD and is a major predictor for liver-related and overall mortality in individuals with NAFLD. The process of fibrosis progression is not completely understood, and it can vary considerably from one individual to another. Several risk factors for fibrosis progression have been identified: age, hypertension, obesity and type 2 diabetes. As of to date, no treatment is available that proved to be successful to target hepatic fibrosis. The only therapeutic options currently available therefore are the control of the concomitant metabolic diseases in addition to diet and lifestyle changes. Unfortunately, this inevitably will lead to polypharmacy and thereby decreases treatment adherence and increases the risk of adverse events and interactions with other drugs.
Recently, cellular senescence has been put forward as a causal factor in the development and progression of NAFLD and NAFLD related liver fibrosis. Cellular senescence is one of the hallmarks of aging and is defined as a stable arrest of the cell cycle coupled to specific phenotypic changes. Senescent cells secrete a collection of proteins called the senescence-associated secretory phenotype (SASP). This pro-inflammatory secretome drives age-related tissue dysfunction. Interestingly, metabolic dysregulation is thought to favor cellular senescence in several tissues involved in the pathogenesis of NAFLD such as the liver, pancreas and adipose tissue, further perpetuating metabolic dysregulation. Of interest, cellular senescence can be targeted using senolytics. The combination of dasatinib, which is an EMA-approved tyrosine kinase inhibitor and the antioxidant quercetin, which is a flavonol present in many fruits and vegetables, successfully clears senescent cells. Recent work in humans and rodents have shown that tissue function, including liver metabolism, can be recovered by clearing senescent cells with senolytics including.
Due the potential role of senescence in NAFLD related fibrosis, dasatinib plus quercetin might thus be an interesting future therapeutic option to tackle NAFLD related fibrosis. Based on the long-term safety profile of these treatments and the high unmet clinical need as there currently is no treatment for NAFLD we aim to perform a double-blind randomized controlled proof-of-principle study in which patients with NAFLD related liver fibrosis will be treated with dasatinib plus quercetin intermittently three days per week for three weeks, followed by a four-week medication-free period. Subsequently, this treatment cycle will be repeated three times
- Conditions
- NAFLD, NASH With Fibrosis, Liver Fibrosis
- Being tested
- Dasatinib 100 MG + Quercetin (1000 MG), Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib 100 MG + Quercetin (1000 MG)Drug
The intervention group will receive intermittent orally administered dasatinib (100 mg/day) plus quercetin (1000 mg/day) on three consecutive days for three consecutive weeks followed by a four-week medication free period. This cycle will be repeated three times.
PlaceboOther
The placebo group will receive intermittent orally administered placebo tablets on three consecutive days for three consecutive weeks followed by a four-week medication free period. This cycle will be repeated three times.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib plus Quercetin | Active comparator | Day 0: (15 per arm, randomization). week 7: blood, fibroscan, ECG, questionnaires. week 14: blood, fibroscan, ECG, questionnaires. Week 21: blood, fibroscan, ECG, questionnaires, liver biopsy. end of study Receives: Drug: Dasatinib 100 MG + Quercetin (1000 MG) |
| placebo | Placebo comparator | Day 0: (15 per arm, randomization). week 7: blood, fibroscan, ECG, questionnaires. week 14: blood, fibroscan, ECG, questionnaires. Week 21: blood, fibroscan, ECG, questionnaires, liver biopsy. end of study Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the binary outcome improvement of fibrosis with at least 1-point without worsening of fibrosis and NAFLD score based on histology after 21 weeks (yes/no). Individuals will be labeled as responder or non-responder.
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
Secondary outcomes (39)
Mean change in number of senescent cells at baseline and end of treatment
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
Percent of patients with reversal of NAFLD (Steatosis without ballooning and with or without mild inflammation) and no worsening of fibrosis) from baseline to end of treatment
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
Global hepatic mRNA expression baseline to end of treatment
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
Change in NAFLD activity score (NAS)
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
change in Activity component of steatosis-activity-fibrosis (SAF) score: steatosis -1 point, lobular inflammation -1 point, ballooning -1 point
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
- Differences in EPOS 7-tier staging system score baseline to end of treatment
As assessed on the obtained liver biopsies before and after the treatment
Measured: 21 week
change in Fibrosis-4 score (Fib-4 score)
Based on blood obtained before and after the treatment
Measured: 21 week
Change in NAFLD Fibrosis Score (NFS)
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in Liver enzymes
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in Liver synthesis function
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in liver stiffness and liver steatosis (with controlled attenuation parameter) measurement by Fibroscan
Based on Fibroscan scores obtained before and after the treatment
Measured: 21 weeks
Change in Glycosylated haemoglobin type A1c (HbA1c)
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in Fasting plasma glucose (FPG)
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in Fasting glucagon
Based on blood obtained before and after the treatment
Measured: 21 weeks
Change in Fasting insulin
Based on blood obtained before and after the treatment
Measured: 21 weeks
change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Based on blood obtained before and after the treatment
Measured: 21 weeks
Glucose variability (determined by 2 weeks of Freestyle libre at begin and end of the trial.
Based Freestyle libre data
Measured: 21 weeks
Change in RAND-36 questionnaires
Based on the questionnaires obtained before and after the treatment
Measured: 21 week
Change in EQ-5D-5L questionnaires
Based on the questionnaires obtained before and after the treatment
Measured: 21 week
Safety endpoints
- Number of treatment-emergent adverse events during the trial
- Number of treatment-emergent myelosuppression
- Number of treatment emergent infections
- Number of subjects discontinuing treatment due to gastrointestinal adverse events
Measured: 21 weeks
Effect of dasatinib plus quercetin on
Pulse baseline vs end of treatment (week 21)
Measured: week 21
Effect of Dasatinib and Quercetin on
QTC time on ECG baseline versus end of treatment (Week 21)
Measured: 21 weeks
Change in weight before after treatment
KG
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
changes in haemoglobin levels (mmol/l)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
changes in creatinine (micromol/L)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
Fecal microbiota composition by 16s sequencing
Measured: 21 weeks
Effect of Dasatinib and quercetin on
Changes in systolic blood pressure before and after treatment
Measured: 21 weeks
Effect of dasatinib and quercetin on
Changes in diastolic blood pressure before and after treatment
Measured: 21 weeks
Changes in BMI before and after treatment with dasatinib and quercetin
BMI (weight /heigt^2)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
amount of thrombocytes ( 10^9/L)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
erythrocytes (10^12/L)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
leucocytes (10^9/L)
Measured: 21 weeks
Effect of Dasatinib and quercetin on
Differential White bloodcell count (%)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
urea (mmol/l)
Measured: 21 weeks
Effect of Dasatinib and quercetin on
bilirubin (total) levels (umol/L)
Measured: 21 weeks
Effect of Dasatinib and Quercetin on
alkaline phosphatase levels (U/L)
Measured: 21 weeks
Effect of Dasatinib and quercetin on
Sodium levles (mmol/L)
Measured: 21 weeks
Effect of Dasatinib and quercetin on
potassium levels (mmol/L)
Measured: 21 weeks
Effect of Dasatinib and quercetin on
Calcium levels(mmol/L)
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start5 Jul 2023
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled proof-of-principle study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Max Nieuwdorp, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506488
- Sponsor's protocol ID
- 2022.0213
- Status last verified
- Dec 2025
- First submitted
- 15 Aug 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koning M, Kovynev A, Fondevila MF, Ruhe EJM, Mommersteeg MC, Ramakers C, Hutten BA, Verwer B, Vlug M, Kuiper T, van den Berg M, Vrieze A, Bizino M, van den Beld A, Berk L, Boerlage T, Augustijn QJJ, Brouwer WP, Chen WJ, Cahen D, Verdonk R, de Jonge WJ, Ramsoekh S, Doukas M, Vermorgen SMM, Verheij J, Beuers U, Takkenberg RB, Bergman JJG, D'Haens GRAM, Drenth JPH, Tchkonia T, Schnabl B, Kirkland JL, Meijnikman AS. Senolytics dasatinib and quercetin in metabolic dysfunction-associated steatohepatitis: a proof-of-principle randomized, controlled trial. Nat Metab. 2026 Oct 1. doi: 10.1038/s42255-026-01643-4. Online ahead of print.
PubMed 42823536
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dasatinib and Quercetin, a Combination of Senolytics to Treat Fibrotic Non-alcoholic Fatty Liver Disease - the TRUTH Study
- ClinicalTrials.gov ID
- NCT05506488
- Acronym / sponsor ID
- 2022.0213
- Conditions
- NAFLD, NASH With Fibrosis, Liver Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effect of dasatinib plus quercetin on liver fibrosis in individuals with biopsy proven NAFLD with fibrosis by performing a double-blind randomized controlled proof-of-principle study
Detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is estimated to affect approximately 25-30% of the population in Western countries and is now the leading cause of chronic liver disease globally. NAFLD is a progressive liver disease and approximately 30% of individuals progress from simple steatosis to Non-Alcoholic Steatohepatitis (NASH), which can further progress to cirrhosis and hepatocellular carcinoma. In the Netherlands, it is estimated that 2.5 million people have NAFLD and this number is thought to increase by 50% in the next 10 years driven by an increasing prevalence of obesity and type 2 diabetes, and an ageing population. Independent of other cardiometabolic diseases, cardiovascular disease is the leading cause of death in individuals with NAFLD, followed by extrahepatic malignancies and liver-related complications. NAFLD results in sustained healthcare costs and economic losses, and reduced health-related quality of life.
It is now widely accepted that liver fibrosis is a result of liver injury secondary to NAFLD and is a major predictor for liver-related and overall mortality in individuals with NAFLD. The process of fibrosis progression is not completely understood, and it can vary considerably from one individual to another. Several risk factors for fibrosis progression have been identified: age, hypertension, obesity and type 2 diabetes. As of to date, no treatment is available that proved to be successful to target hepatic fibrosis. The only therapeutic options currently available therefore are the control of the concomitant metabolic diseases in addition to diet and lifestyle changes. Unfortunately, this inevitably will lead to polypharmacy and thereby decreases treatment adherence and increases the risk of adverse events and interactions with other drugs.
Recently, cellular senescence has been put forward as a causal factor in the development and progression of NAFLD and NAFLD related liver fibrosis. Cellular senescence is one of the hallmarks of aging and is defined as a stable arrest of the cell cycle coupled to specific phenotypic changes. Senescent cells secrete a collection of proteins called the senescence-associated secretory phenotype (SASP). This pro-inflammatory secretome drives age-related tissue dysfunction. Interestingly, metabolic dysregulation is thought to favor cellular senescence in several tissues involved in the pathogenesis of NAFLD such as the liver, pancreas and adipose tissue, further perpetuating metabolic dysregulation. Of interest, cellular senescence can be targeted using senolytics. The combination of dasatinib, which is an EMA-approved tyrosine kinase inhibitor and the antioxidant quercetin, which is a flavonol present in many fruits and vegetables, successfully clears senescent cells. Recent work in humans and rodents have shown that tissue function, including liver metabolism, can be recovered by clearing senescent cells with senolytics including.
Due the potential role of senescence in NAFLD related fibrosis, dasatinib plus quercetin might thus be an interesting future therapeutic option to tackle NAFLD related fibrosis. Based on the long-term safety profile of these treatments and the high unmet clinical need as there currently is no treatment for NAFLD we aim to perform a double-blind randomized controlled proof-of-principle study in which patients with NAFLD related liver fibrosis will be treated with dasatinib plus quercetin intermittently three days per week for three weeks, followed by a four-week medication-free period. Subsequently, this treatment cycle will be repeated three times
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled proof-of-principle study
| Arm | Type | Receives |
|---|---|---|
| Dasatinib plus Quercetin | Active comparator | Drug: Dasatinib 100 MG + Quercetin (1000 MG)Day 0: (15 per arm, randomization). week 7: blood, fibroscan, ECG, questionnaires. week 14: blood, fibroscan, ECG, questionnaires. Week 21: blood, fibroscan, ECG, questionnaires, liver biopsy. end of study |
| placebo | Placebo comparator | Other: PlaceboDay 0: (15 per arm, randomization). week 7: blood, fibroscan, ECG, questionnaires. week 14: blood, fibroscan, ECG, questionnaires. Week 21: blood, fibroscan, ECG, questionnaires, liver biopsy. end of study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult individuals, age > 18 years
- NAFLD with fibrosis score >2 according to the Steatosis Activity and Fibrosis score, but no cirrhosis histological diagnosis according to the SAF fibrosis score on a liver biopsy performed < 6 months before screening in the study and confirmed by central reading during the screening period.
- Individuals agrees to have a liver biopsy performed after the treatment
- Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol:
- Have a stable weight since the liver biopsy was performed defined by no more than a 5% loss of initial body weight
Key exclusion criteria (15 listed)
- Evidence of another form of liver disease
- History of sustained excess alcohol ingestion: daily consumption >30g/day (3 drinks per day) for males and >20 g/day (2 drinks per day) for females
- Unstable metabolic condition: weight change > 5 kg in the last three months, diabetes with poor glycaemic control (HbA1c > 8.5%), introduction of an antidiabetic or of an anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the past 6 months prior to screening
- Bariatric surgery
- ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose oestrogens, methotrexate, tetracycline or amiodarone in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib 100 MG + Quercetin (1000 MG)The intervention group will receive intermittent orally administered dasatinib (100 mg/day) plus quercetin (1000 mg/day) on three consecutive days for three consecutive weeks followed by a four-week medication free period. This cycle will be repeated three times. | Drug | Dasatinib plus Quercetin |
| PlaceboThe placebo group will receive intermittent orally administered placebo tablets on three consecutive days for three consecutive weeks followed by a four-week medication free period. This cycle will be repeated three times. | Other | placebo |
Primary outcome
The primary endpoint is the binary outcome improvement of fibrosis with at least 1-point without worsening of fibrosis and NAFLD score based on histology after 21 weeks (yes/no). Individuals will be labeled as responder or non-responder.
Time frame: 21 week
As assessed on the obtained liver biopsies before and after the treatment
39 secondary outcomes
Mean change in number of senescent cells at baseline and end of treatment
Time frame: 21 week
Percent of patients with reversal of NAFLD (Steatosis without ballooning and with or without mild inflammation) and no worsening of fibrosis) from baseline to end of treatment
Time frame: 21 week
Global hepatic mRNA expression baseline to end of treatment
Time frame: 21 week
Change in NAFLD activity score (NAS)
Time frame: 21 week
change in Activity component of steatosis-activity-fibrosis (SAF) score: steatosis -1 point, lobular inflammation -1 point, ballooning -1 point
Time frame: 21 week
- Differences in EPOS 7-tier staging system score baseline to end of treatment
Time frame: 21 week
change in Fibrosis-4 score (Fib-4 score)
Time frame: 21 week
Change in NAFLD Fibrosis Score (NFS)
Time frame: 21 weeks
Change in Liver enzymes
Time frame: 21 weeks
Change in Liver synthesis function
Time frame: 21 weeks
Change in liver stiffness and liver steatosis (with controlled attenuation parameter) measurement by Fibroscan
Time frame: 21 weeks
Change in Glycosylated haemoglobin type A1c (HbA1c)
Time frame: 21 weeks
Change in Fasting plasma glucose (FPG)
Time frame: 21 weeks
Change in Fasting glucagon
Time frame: 21 weeks
Change in Fasting insulin
Time frame: 21 weeks
change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 21 weeks
Glucose variability (determined by 2 weeks of Freestyle libre at begin and end of the trial.
Time frame: 21 weeks
Change in RAND-36 questionnaires
Time frame: 21 week
Change in EQ-5D-5L questionnaires
Time frame: 21 week
Safety endpoints
Time frame: 21 weeks
Effect of dasatinib plus quercetin on
Time frame: week 21
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Change in weight before after treatment
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Effect of dasatinib and quercetin on
Time frame: 21 weeks
Changes in BMI before and after treatment with dasatinib and quercetin
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Effect of Dasatinib and Quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Effect of Dasatinib and quercetin on
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42823536Koning M, Kovynev A, Fondevila MF, Ruhe EJM, Mommersteeg MC, Ramakers C, Hutten BA, Verwer B, Vlug M, Kuiper T, van den Berg M, Vrieze A, Bizino M, van den Beld A, Berk L, Boerlage T, Augustijn QJJ, Brouwer WP, Chen WJ, Cahen D, Verdonk R, de Jonge WJ, Ramsoekh S, Doukas M, Vermorgen SMM, Verheij J, Beuers U, Takkenberg RB, Bergman JJG, D'Haens GRAM, Drenth JPH, Tchkonia T, Schnabl B, Kirkland JL, Meijnikman AS. Senolytics dasatinib and quercetin in metabolic dysfunction-associated steatohepatitis: a proof-of-principle randomized, controlled trial. Nat Metab. 2026 Oct 1. doi: 10.1038/s42255-026-01643-4. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Nieuwdorp, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dasatinib 100 MG + Quercetin (1000 MG) in people with NAFLD and NASH With Fibrosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the binary outcome improvement of fibrosis with at least 1-point without worsening of fibrosis and NAFLD score based on histology after 21 weeks (yes/no). Individuals will be labeled as responder or non-responder. (time frame: 21 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.