The Zydus Group, a leading global healthcare provider, announced that new clinical data on Lipaglyn (Saroglitazar) will be presented at the American Association of Clinical Endocrinologists (AACE) 25th Annual Scientific and Clinical Congress to be held from May 25th to 29th, 2016 at Orlando, Florida, USA.
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. The recommended dose of Lipaglyn is 4 mg once-a-day. Lipaglyn (Saroglitazar) was launched in India during September 2013. Since then more than 300,000 patients have been treated with Lipaglyn in India to date, and data has been presented at several scientific and medical conferences.
In randomized, controlled, phase III clinical studies (PRESS V and PRESS VI) Saroglitazar 4 mg was found to be safe and well tolerated by patients, and demonstrated up to 45 per cent reduction in triglycerides; along with beneficial effects on both lipid and glycemic parameters. Additional phase III trials are ongoing in non-alcoholic steatohepatitis (NASH), lipodystrophy and few additional indications. A post-marketing phase-IV study is currently underway in patients suffering from hypertriglyceridemia in India.
Zydus has initiated a 52 week phase III clinical trial of Lipaglyn in India to treat patients with biopsy proven NASH. Saroglitazar has demonstrated good efficacy in animal models of NASH, along with associated biomarkers. It has reduced hepatic steatosis, ballooning, inflammation and fibrosis in liver. The recently concluded phase 2 studies of Saroglitazar in patients with biopsy proven NASH has shown improvement in liver enzymes along with favourable effects on lipid and glycemic indices.