Zydus Cadila reported the phase 2 EVIDENCES IV trial, evaluating saroglitazar magnesium, in patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) has achieved the primary endpoints. This study is one of several EVIDENCES trials conducted to assess the effect of Saroglitazar Magnesium in various populations with NAFLD, including patients with NASH.
The EVIDENCES IV NASH trial was a randomized, double-blind, placebo-controlled study that enrolled 106 patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including Non-Alcoholic Steatohepatitis (NASH) across 20 clinical sites in the United States. Patients were randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks.
The primary endpoint of the study was percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group. There was a statistically significant 44.39% reduction in mean ALT from baseline to week 16 observed with all doses of Saroglitazar as compared to placebo. A statistically significant reduction in hepatic fat content from baseline was also observed in patients treated with Saroglitazar Magnesium as compared to placebo following 16 weeks of treatment as measured by MRI-PDFF. The secondary endpoints of the trial also included measurements of other Liver enzymes, Insulin resistance, Liver fibrosis, BMI, Waist circumference, MRI-derived measures of total liver fat index, Lipid and lipoprotein levels, and pharmacokinetic parameters.
Zydus plans to present the detailed data in upcoming scientific conferences and to publish the study findings in peer-reviewed scientific journals.
An estimated 6.5 million adults in the United States and five major European countries have been diagnose as having advanced NASH. NASH is a progressive disease of the liver. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure. There are currently no treatments approved by the U.S. FDA for treatment of NASH.
About Saroglitazar Magnesium
Saroglitazar Magnesium acts as a dual PPAR agonist at the subtypes α (alpha) and γ (gamma) of the peroxisome proliferator-activated receptor (PPAR). Agonist action at PPARα lowers high blood triglycerides, and agonist action on PPARγ improves insulin resistance and consequently lowers blood sugar. Nonclinical studies have demonstrated that Saroglitazar, because of its unique mechanism of engaging PPAR alpha and PPAR gamma, favorably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis.