Clinical Research Directory

Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease

This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in adults with Non-Alcoholic Fatty Liver Disease (NAFLD). A total of 170 adults aged 18-60 years with uncomplicated NAFLD (fibrosis stage up to F2) will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for a treatment duration of 24 weeks. Standard of care includes dietary and lifestyle modifications, exercise recommendations, and management of comorbid conditions as per routine clinical practice. The study aims to assess the efficacy of Picroliv in improving hepatic and metabolic parameters and to evaluate its safety profile compared with placebo. Participants will be followed for a total study duration of 48 weeks. The trial will be conducted across six clinical sites in India.

Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as type 2 diabetes, metabolic syndrome and dyslipidemia. Bempedoic acid, an ATP-citrate lyase inhibitor, is recently approved for patients with dyslipidemia as a second line drug. Bempedoic acid reduces liver fat in mice model of NASH. Data regarding the effect of bempedoic acid on human liver fat are scarce. Therefore, the current study is planned to evaluate the effect of bempedoic acid versus standard treatment on liver and pancreatic fat content in patients with NAFLD

Dapagliflozin in Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes Mellitus Patients (T2DM).

Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance. Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.

Efficacy of Sodium Glucose Cotransporter 2 Inhibitors on Non-Alcoholic Fatty Liver Disease

evaluate the effectiveness of sodium-glucose cotransporter-2 (SGLT.2) inhibitors in improving hepatic steatosis and hepatic fibrosis using imaging biomarkers and histopathology in patients with non-alcoholic fatty liver disease