Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified Health Condition 2: null- Nonalcoholic Fatty Liver Disease
Conditions
Interventions
Intervention1: Saroglitazar
4mg: Dosage:-4 Mg Route:- Oral Frequency :-Once daily Duration :-24
weeks
Control Intervention1: Placebo: Route:- Oral Frequency :-Once daily Duration :-24 weeks
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or females, 18 to 65 years of age. 2. Diagnosis of NAFLD established either by imaging [ultrasound, computed tomography (CT) scan or magnetic resonance imaging (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 (Chalasani et al. Hepatology 2012; 55:2005-2023). (a) hepatic steatosis by imaging or histology, (b) no significant alcohol consumption, (c) no competing etiologies for hepatic steatosis, and (d) no co-existing causes for chronic liver disease. 3. Patients with steatosis >= 10 % as assessed by MRI at the Screening. 4. ALT level of >= 1.5 Ã? ULN at screening. 5. Patientâ??s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations; provision of written informed consent form before any study specific tests or procedures are performed.
Exclusion criteria
Exclusion criteria: 1.Use of vitamin E ( >400 IU/day) or multivitamins containing vitamin E ( >400 IU/day) in the 3 months preceding enrollment. 2.Use of drugs with potential effect on NAFLD/NASH such as ursodeoxycholic acid, S-adenosylmethionine (SAM-e), betaine, pentoxifylline 1 month prior to enrollment. 3.Fibrates (clofibrate, fenofibrate) in the 3 months prior enrollment. 4.Use of thiazolidinedione (pioglitazone, rosiglitazone). 5.History of bowel surgery (gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplant (OLT) or listed for OLT. 6.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis. 7.Patient has known cirrhosis, either based on clinical criteria or liver histology or Fibroscan®. 8.Patient with International normalized ratio (INR) >1.3. 9.Type 1 diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver fat content as measured by non-invasive magnetic resonance imaging (MRI) at week 24.Timepoint: 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of a 24-week treatment regimen of saroglitazar 4 mg on the following parameters in patients with NAFLD: 1. Liver stiffness as measured by transient elastography/FibroScan® 2. Serum alanine aminotransferase (ALT) levelTimepoint: 24 week | — |
Countries
India
Contacts
Public ContactDr Manjunath K
Cadila Healthcare Limited
Outcome results
None listed