Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar Magnesium: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.
Intervention2: Vitamin E: Patients rando
Sponsors
Asian Institute of Gastroenterology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (age 18 to 60) 2. Confirmed Diagnosis of NAFLD established either by imaging (ultrasound, CT scan or MRI) or liver biopsy showing simple steatosis, within 6 months of the Screening Phase for this study. The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017). (a) There is hepatic steatosis by imaging or histology, (b) There is no significant alcohol consumption, (c) There are no competing etiologies for hepatic steatosis (d) There are no co-existing causes for chronic liver disease. 3. Patientâ??s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations. 4. Either take biopsy proven NAFLD or imaging based NAFLD with ALT more than 1.5 times the upper limit of normal. (being considered as 32) 5. Liver biopsy would be done in selected cases where the cause of transaminitis was uncertain of possible biopsy would be done on case to case basis.
Exclusion criteria
Exclusion criteria: 1. Absence of regular or excessive use of alcohol within 2 years prior to initial screening. 2. Presence of alternative causes of fatty liver. ï?? Weight loss >10% in the 6 months before the Screening Visit ï?? Total parenteral nutrition, starvation or protein-calorie malnutrition ï?? Use of drugs associated with NAFLD for more than 12 consecutive weeks in the 1 year before start of the study, including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L asparaginase, valproate, chloroquine, or antiretroviral drugs. 3. History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) or listed for OLT. 4. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis. 5. Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques. 6. Patients with Hypothyroidism. 7. Patients with unstable cardiovascular disease including, ï?? unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III â?? IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months ï?? history of (within prior 3 months) or current unstable cardiac dysarrhythmias ï?? uncontrolled hypertension (systolic BP >180 mmHg and/or diastolic BP >110 mmHg on two consecutive occasions) ï?? stroke or transient ischemic attack within the prior 6 months 8. History of myopathies or evidence of active muscle disease. 9. History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial non-melanoma skin cancer. 10. Participation in any other therapeutic clinical study in the past 3 months, including participation in any other NAFLD clinical trials. 11. History of bladder disease and/or hematuria or has current hematuria except due to a urinary tract infection. 12. Illicit substance abuse within the past 12 months. 13. Pregnant/lactating female (including positive pregnancy test at the Screening Visit) 14. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption). 15. Patients who will not comply with diet and lifestyle changes can be excluded from the final analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in NAFLD fibrosis score at 8week, 16week and 24week. 2. Compare the overall efficacy of patients with NAFLD/ NASH treated with Saroglitazar magnesium, vitamin E and Saroglitazar magnesium with Vitamin E and Life style modifications alone. 3. Determine the safety profile of these regimens in those patients.Timepoint: 2 month, 4 month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum alanine aminotransferase (ALT) & aspartate aminotransferase (AST) level. 2. Serum triglycerides (TG) level, high-density lipoprotein (HDL), low density lipoprotein (LDL) & fasting plasma glucose (FPG)/glycosylated haemoglobin (HbA1c). 3. Liver Biopsy at 24week in selected patients.Timepoint: 2 month, 4 month, 6 month | — |
Countries
India
Contacts
Public ContactMithun Sharma
Asian Institute of Gastroenterology
Outcome results
None listed