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New treatment option for NASH - Nonalcoholic Steatohepatitis
Official title Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT04697810
What this study is testing
What is Namodenoson?
Namodenoson is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nash - nonalcoholic steatohepatitis.
Also referred to as CF102.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age.
- AST at Screening of ≥20 IU/L.
- FibroScan LSM ≥8.5 kPa
- 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...
- Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).
You likely can't join if
- Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
- Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular...
- Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
- Weight loss of \>5% within 3 months prior to Baseline.
- History of bariatric surgery within 5 years of Screening.
- Diabetes mellitus other than Type II.
See the full eligibility criteria
- At least 18 years of age.
- AST at Screening of ≥20 IU/L.
- FibroScan LSM ≥8.5 kPa
- 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)...
- Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).
- 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).
- 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).
- 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
- Female people 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...
- Male people must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male people with fertile or pregnant partners must agree to use condoms throughout the course...
- Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.
- Understand and provide written informed consent to participate.
- Willing to undergo 2 liver biopsies.
- Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
- Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
- Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.
- Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
- Weight loss of \>5% within 3 months prior to Baseline.
- History of bariatric surgery within 5 years of Screening.
- Diabetes mellitus other than Type II.
- Hemoglobin A1c \>9.0% (people with diabetes).
- Any contraindication to percutaneous liver biopsy.
- 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.
- 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...
- Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.
- Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \>10 mg prednisone-equivalent concurrently or within 1 year.
- More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.
- Uncontrolled or clinically unstable thyroid disease.
- 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.
- Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.
- QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \> 450 milliseconds (msec) for males or \> 470 msec for females.
- A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.
- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.
- Active gastrointestinal disease which could interfere with the absorption of oral medication.
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.
The study team makes the final eligibility decision.
Where it's taking place
- Banja Luka, Bosnia and Herzegovina
- Prijedor, Bosnia and Herzegovina
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Beersheba, Israel
- Jerusalem, Israel
- Chisinau, Moldova
- Bucharest, Romania
- Cluj-Napoca, Romania
- Craiova, Romania
- Timișoara, Romania
- Belgrade, Serbia
- Niš, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banja Luka, Bosnia and Herzegovina; Prijedor, Bosnia and Herzegovina; Plovdiv, Bulgaria; Rousse, Bulgaria; Sofia, Bulgaria; Beersheba, Israel and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.