Zydus Cadila has received US health regulator United States Food and Drug Administration’s (USFDA) nod to initiate phase II clinical trials of Sarolitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits. This 12-week trial will evaluate three doses of Saroglitazar in the strengths of 1 mg, 2 mg and 4 mg versus placebo.
The primary endpoint of the study is percent change in triglycerides from baseline after 12 weeks of dosing. Patients with severe hypertriglyceridemia often have to take multiple medications because of associated diabetes or fatty liver disease.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.
