To assess the Effect of Saroglitazar on Fatty Liver Index and Fibroscan parameters [Linear Shear Measurement (LSM) and Controlled Attenuation Parameters (CAP)] in patients of Non Alcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) involves fat accumulation in the liver (hepatic steatosis) without significant alcohol consumption or secondary causes. It is a common chronic liver disease, affecting approximately 25-30% of the global population, and can progress to more severe forms like non-alcoholic steatohepatitis (NASH). NASH can lead to fibrosis, cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC), marking it as a significant cause for liver transplantation.

Pathophysiology: NAFLD’s progression is associated with insulin resistance and various cellular changes, including oxidative stress, inflammation, and hepatocyte damage. Key proinflammatory cytokines like TNF-α, MCP-1, and IL-6 contribute to the disease process, driving the progression from NAFL to NASH and inducing hepatic inflammation and fibrosis.

Symptoms: Many patients are asymptomatic; however, some may report fatigue, right upper quadrant discomfort, or hepatomegaly. Signs of chronic liver disease are rare at diagnosis.

Treatment Options: While only Pioglitazone and vitamin E are approved for treating NAFLD/NASH, Saroglitazar, a dual PPAR-α and PPAR-γ agonist, has been recently approved for treating NAFLD in India. Saroglitazar enhances lipid oxidation and insulin sensitivity, reducing lipotoxicity and showing positive effects in clinical trials, such as improvements in hepatic steatosis, inflammation, and metabolic parameters.

Clinical Studies: Recent studies illustrate Saroglitazar’s efficacy in reducing liver enzymes (ALT, AST), liver stiffness (measured by FibroScan), and improving lipid profiles in NAFLD patients. Various trials report significant reductions in hepatic fat content, transaminases, and improvements in biochemical markers across different populations, including those with and without diabetes.

Research Focus: The proposed study aims to assess the effects of Saroglitazar on fatty liver index parameters and FibroScan results in patients diagnosed with NAFLD. This will involve a prospective observational design assessing biochemical, histological, and FibroScan parameters at baseline and after 3 and 6 months of treatment.

Objectives:

• Assess the impact of Saroglitazar on liver fibrosis and steatosis.
• Evaluate changes in liver function and lipid profiles in patients with NAFLD.

Methodology:Patients aged 18-65 with diagnosed NAFLD will undergo baseline evaluations, including liver function tests, lipid profiles, ultrasounds, and FibroScan. Saroglitazar (4 mg) will be administered daily for three months, with follow-up assessments conducted at three and six months to monitor changes in liver function, lipid profiles, and steatosis severity.

This comprehensive approach would contribute to evaluating Saroglitazar’s therapeutic potential, paving the way for more effective treatment strategies for NAFLD.