Zydus Cadila completed patient enrollment in its phase 2 trial of Lipaglyn for the treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, according to a press release.
Lipaglyn (saroglitazar magnesium) is an investigational molecule that has demonstrated a unique mechanism of engaging PPAR alpha and PPAR gamma.
The company enrolled 104 patients with NAFLD or NASH who will receive 1 mg, 2 mg or 4 mg of saroglitazar magnesium or matching placebo for 16 weeks. The primary endpoint will be the percentage of change from baseline in serum alanine aminotransferase at week 16 compared with placebo.
Additionally, the researchers will evaluate change in liver fat content as measured by magnetic resonance imaging along with several other secondary endpoints.
“This is a major milestone in our innovation journey, and we hope to report the top line results of this trial by the end of the year,” Pankaj R. Patel, chairman of Zydus, said in the release. “In keeping with our mission of creating healthier, happier communities, we are committed towards developing this drug for millions of patients suffering from NASH, an unmet health care need."