Zydus’ Saroglitazar meets primary goal in global Phase II(b) MASH trial

Ahmedabad-based drugmaker Zydus Lifesciences has said that its drug Saroglitazar Magnesium has met the primary goal of a global Phase II(b) trial for Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis, a serious liver disease linked to metabolic disorder.

Zydus said that a liver biopsy-driven EVIDENCES-X study that enrolled 189 subjects successfully met its primary endpoint of resolving steatohepatitis, or liver inflammation and injury, without worsening of fibrosis or liver scarring after 52 weeks of treatment. The development is significant for Zydus as it strengthens the drugmaker’s development programme for the progressive liver disease.

In addition to achieving the primary endpoint, the study demonstrated encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation and ballooning assessments, the company added.


“The successful completion of the EVIDENCES-X Phase II(b) trial and achievement of the primary endpoint marks an important milestone in our MASH development programme. These results reinforce the therapeutic potential of Saroglitazar Mg and our commitment to developing innovative treatment options for patients suffering from chronic liver diseases,” said Zydus Lifesciences Managing Director Sharvil Patel.

Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) and MASH, continue to represent significant unmet medical needs globally. Experts estimate that approximately 25% of adults worldwide are affected by MASLD, while MASH affects an estimated 5% to 20% of the adult population. MASH is characterised by hepatic steatosis, inflammation, and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure, liver cancer, and death.

The positive results build upon previously published findings from earlier Phase II studies of Saroglitazar in MASH and MASLD patients. Data from the EVIDENCES-X trial will be presented at upcoming scientific meetings and submitted for publication in a peer-reviewed medical journal.

Saroglitazar Mg was approved by the Drug Controller General of India (DCGI), for the treatment of MASH and MASLD in India in 2020. It is an investigational compound in the US and has not yet been approved by the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH and MASLD.