To study effect of Livitol in treatment of patients diagnosed with moderate to severe non-alcoholic fatty liver.
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/04/041926
- Lead Sponsor
- Dr Reddys Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
1. Age 18-65 years at study entry.
2. Male, or female diagnosed with non-alcoholic fatty liver (steatosis), but if female, meets all the following criteria:
a. Not breastfeeding
b. Post-menopausal or negative urine pregnancy test result at Screening /Visit 1 (not required for hysterectomized females).
c. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last
3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study.
3. Patients diagnosed with moderate to severe fatty liver based on ultrasound (if ultrasound is available within 3 months of screening, it would be considered valid for screening).
4. Patients with liver fat greater than 15% as measured by MRI-PDFF at Screening.
5. Can read, understand, and sign the informed consent form (ICF) and communicate with the investigator, and understand and comply with protocol requirements.
1. eGFR less than 60ml/min/1.73m2 at screening (chronic kidney disease epidemiology collaboration [CKD-EPI] formula).
2. Elevation of AST or ALT greater than five times upper limit normal (ULN).
3. Evidence of significant alcohol consumption (defined as more than 7 drinks/week for females and greater than 14 drinks/week for males) within 6 months prior to randomization
4. Body Mass Index (BMI) more than or equal to 40 kg/m2
5. Use of any of the following medications in the last 12 weeks prior to screening visit:
a. Metformin greater than 2 g/day
b. Insulins – all forms
c. Use of sildenafil, tadalafil, vardenafil, pioglitazone, rosiglitazone, alpha blockers, oral nitrates.
d. Medications associated with increased hepatic steatosis.
Commonly used medications associated with drug induced hepatic steatosis include amiodarone, valproate, tamoxifen, methotrexate, and some chemotherapeutic and antiretroviral agents, and steroids.
e. Organic Cation Transporter 2/MATE inhibitors (Includes
multidrug and toxin extrusion protein 1 and multidrug and toxin
extrusion protein 2 inhibitors like:
i. Methotrexate
ii. Tamoxifen
f. Corticosteroids (Nasal steroids are allowed if the subject has been on a stable dose for the past 12 weeks and the dose employed does not exceed the maximal recommended dose)
g. Estrogens
h. Amiodarone
i. Valproic acid
j. Coumadin
k. Isoniazide
l. Nucleoside analogues used for the treatment of human
immunodeficiency virus (HIV) infections
m. Any dietary supplement including Vitamin E and L-Carnitine other than multi-vitamins.
6. Presence or suspicion of other forms of chronic liver disease (e.g., cirrhosis, autoimmune hepatitis (greater than 1 is to 160 Anti-Nuclear Antibody ANA), Wilsons disease, Hemochromatosis (Ferritin greater than 1000 ug/L and percent iron saturation
greater than 45 percent), hepatitis A, B or C), primary biliary cholangitis, primary sclerosing cholangitis, Wilsons disease, homozygous alpha 1 anti trypsin deficiency.
7. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
a. Unable to undergo MRI or contraindications for MRI procedure
b. History of cardio or cerebro vascular disease event within the previous 6 months
c. Requires anti coagulation therapy
d. Gastrointestinal disorders including, but not limited to, the following:
pancreatitis, inflammatory bowel disease, or other diseases associated with malabsorption or persistent abdominal discomfort
e. Endocrine disorders, other than type 2 diabetes and hypothyroidism on stable replacement therapy for 3 months prior to enrolment.
f. Chronic infection (e.g., tuberculosis, HIV infection, hepatitis A virus, hepatitis B virus, or hepatitis C virus)
g. Neurological or psychiatric diseases that preclude valid execution of informed consent or may interfere with the subjects compliance with study procedures (e.g., major depressive disorder within the last 2 years, a history of suicidal behaviour in the last 3 months). This will be based on investigator’s opinion and does not need formal psychological screening.
h. History of other psychiatric disorders including schizo
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hepatic Fat contentTimepoint: Baseline, Week 24
- Secondary Outcome Measures
Name Time Method 1. To evaluate the change from baseline in fatty liver grading using the 4 ultrasound criteria or signs <br/ ><br>2. To evaluate the change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and <br/ ><br>gamma-glutamyl transferase (GGT) levels <br/ ><br>3. To evaluate the change in hemoglobin A1c / glycated hemoglobin (HbA1C), fasting glucose, fasting insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR) <br/ ><br>4. To evaluate the change in cholesterol, low density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, and free fatty acid (FFA) <br/ ><br>5. To evaluate the change in fibrosis-4 (FIB-4) score. <br/ ><br> <br/ ><br>Secondary Safety Endpoints: <br/ ><br>a. Adverse events <br/ ><br>b. Serious adverse events <br/ ><br>c. Significant changes in: <br/ ><br>d. Vital signs <br/ ><br>e. Physical examination findings <br/ ><br>f. Laboratory derangements <br/ ><br>g. Electrocardiogram (ECG) findings.Timepoint: Baseline Week 12, Week 24