Zydus to start phase-II clinical trials for Saroglitazar in US

The drug is used for treatment of Hypertriglyceridemia and Diabetic Dyslipidemia

Ahmedabad-based pharmaceutical major Cadila Healthcare (Zydus Cadila) today announced the US drug regulator has endorsed company's plan to initiate a phase-II clinical trial of Saroglitazar, a medicine for the treatment of Hypertriglyceridemia and Diabetic Dyslipidemia.

It said in a statement, "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 USA."

The primary endpoint of the study is a per cent 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 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).

Lipaglyn (Saroglitazar) is a rationally designed novel drug developed after 12 years of scientific efforts and extensive preclinical and clinical investigations, including more than 25 months of real-time clinical experience at the time of this reporting in patients in India.

Lipaglyn (Saroglitazar) is currently 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.

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."

Lipaglyn (Saroglitazar) was launched in India during September 2013. Since then more than 150,000 patients have been treated with Lipaglyn in India to date.