Ahmedabad-based Zydus Group on Thurday informed it had initiated of Phase-III trials of the Lipaglyn drug for patients suffering from lipodystrophy.
According to the company's statement, the trials were aimed at evaluating the safety and efficacy of Lipaglyn 4 mg versus standard-of-care with placebo in the treatment of lipodystrophy (a medical condition characterised by abnormal or degenerative conditions of the body fat).
The move is seen as the newer therapeutic usage of its breakthrough drug Lipaglyn (Saroglitazar), which is already approved in India for the treatment of diabetic dyslipidemia and hypertriglyceridemia.
Lipodystrophy results from a problem with the way fat is produced, used, and stored by the body. Inherited lipodystrophies are caused by gene mutations. Lipodystrophy patients suffer from metabolic disorders, including lipid disorder and insulin resistance, leading to diabetes which could increase the risk for other problems such as heart or liver disease.
According to Pankaj Patel, CMD, Zydus Group, following the launch of Lipaglyn in India, the company continued to pursue additional clinical development in indications having significant unmet needs such as lipodystrophy. The results from the earlier conducted Phase-II studies in patients with lipodystrophy had been encouraging and the company was hopeful of extending the development of LipaglynTM for the treatment of lipodystrophy.
Patients suffering from lipodystrophy tend to develop insulin resistance, diabetes, elevated triglyceride levels (hypertriglyceridemia), and fatty liver.
"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," the company said in a statement in Ahmedabad.