With a view to explore new therapeutic usage of its breakthrough drug Lipaglyn (saroglitazar), the Zydus Group has commenced phase III trials of the molecule for patients suffering from lipodystrophy.  The goal of this trial is to evaluate the safety and efficacy of Lipaglyn 4 mg versus standard-of-care with placebo in the treatment of lipodystrophy.

Lipodystrophy is a problem with the way the body produces, uses, and stores fat, inherited lipodystrophies are caused by mutations in a gene, whereas acquired lipodystrophies are caused by medications, autoimmune mechanisms or unknown mechanisms. Patients with lipodystrophy suffer from metabolic disorders including lipid disorder and insulin resistance that leads to diabetes. These disorders can also increase the risk for other problems such as heart or liver disease.

The drug is already approved in India for treating diabetic dyslipidemia and hypertriglyceridemia. Launched in September 2013, Lipaglyn (saroglitazar) is a breakthrough therapy in the treatment of diabetic dyslipidemia, India's first NCE to reach the market. Since then, thousands of patients have been treated with Lipaglyn in this country. It is a prescription drug available across India and prescribed by cardiologists, diabetologists and general physicians.

Speaking about the latest development Pankaj R Patel chairman and managing director of Zydus Group, said, "Following the launch of Lipaglyn in India we continue to pursue additional clinical development in indications having significant unmet needs such as lipodystrophy. The results from the previously conducted phase II studies in patients with lipodystrophy have been encouraging and we are hopeful of extending the development of Lipaglyn for the treatment of lipodystrophy."

A dual PPAR agonist, Lipaglyn has a predominant affinity to PPAR alpha and moderate affinity to PPAR gamma. This dual action helps reduce triglycerides and LDL (bad) cholesterol and increase HDL (good) cholesterol. It has also showed a reduction in fasting plasma glucose and glycosylated haemoglobin (HbA1c), confirming its beneficial effects of both lipid and glycemic control. With a non-renal route of elimination, Lipaglyn has no adverse events like edema, weight gain, myopathies or derangement of liver and or kidney functions, thus making it safe and efficacious.