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).