Zydus to begin phase 2 clinical trials for saroglitazar in US

The US Food & Drug Administration (FDA) has given nod to Zydus Cadila’s plan to initiate a phase 2 clinical trial of saroglitazar in patients with severe hypertriglyceridemia (TG > 500 mg/dL). This randomised, double-blind 12 week phase 2 trial will evaluate 3 doses of saroglitazar (1 mg, 2 mg and 4 mg) versus placebo.
 
The trial will be conducted across several medical sites in the US. The primary endpoint of the study is percent change in triglycerides from baseline after 12 weeks of dosing.
 
More than four million American adults are living with severe hypertriglyceridemia. High triglyceride levels can lead to increased triglyceride accumulation in the pancreas which puts patients at very high risk of pancreatitis, a serious and potentially life-threatening illness. In addition, excessive accumulation of triglycerides in the liver can cause serious conditions like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
   
Saroglitazar, marketed as Lipaglyn, is already approved in India as a prescription medicine for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type 2 diabetes not controlled by statins.
 
Speaking on the development, Pankaj Patel, chairman and managing director of Zydus Cadila, said, “This development is a significant milestone for Zydus. Patients with severe hypertriglyceridemia often have to take multiple medications because of associated diabetes or fatty liver disease. Zydus is committed to develop Lipaglyn (saroglitazar) for millions of patients living with severe hypertriglyceridemia and fatty liver diseases.”