The US Federal Drug Administration has given the much-awaited nod for second stage clinical tests of obesity reduction drug called Sarolitazar manufactured by Zydus Cadilla.
In a statement, Zydus Cadila said it has received the US drug regulator’s consent for phase II clinical trials of Sarolitazar, to teat high fat individuals with diabetes, obesity and sedentary life-style. “USFDA has endorsed company’s plan to initiate a phase II clinical trial of Saroglitazar in patients with severe hypertriglyceridemia,” Zydus Cadila said.
Since patients with severe hypertriglyceridemia are dependant on several medications due to diabetes or fatty liver disease, the new drug developed by Zydus Cadilla called Lipaglyn (Saroglitazar) will help millions of patinets across the world, said company’s Chairman and Managing Director Pankaj Patel.
The second stage trial will be carried out for 12 weeks to test three doses of Saroglitazar in the strengths of 1 mg, 2 mg and 4 mg versus placebo, said the company. The tests will help analyze percent change in triglycerides from baseline after 12 weeks of trial.
Zydus Cadilla has already received nod to market the drug in India for Lipaglyn from the Drug Controller General of India to treat patients with hypertriglyceridemia and diabetic dyslipidemia in type II diabetes and is selling it in the country since September 2013, said the company.