Exploring newer therapeutic usage of its breakthrough drug Lipaglyn (saroglitazar), India’s Zydus Group has initiated Phase III trials of the molecule for patients suffering from lipodystrophy.
The drug, the first Indian New Chemical Entity (NCE) to reach the market, is already approved in India for treating diabetic dyslipidemia and hypertriglyceridemia. 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. 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.
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