Zydus Lifesciences MASH trial meets primary endpoint with 26.5% treatment difference
- Zydus Lifesciences' EVIDENCES-X Phase II(b) trial for Saroglitazar Mg in MASH met its primary endpoint
- The study showed a 26.5% treatment difference in resolving steatohepatitis without worsening fibrosis
- Trial enrolled 189 subjects over 52 weeks with positive secondary endpoint findings
- Data will be presented at the upcoming Liver Congress
*this image is generated using AI for illustrative purposes only.
Zydus Lifesciences Limited reported positive topline results from its completed EVIDENCES-X Phase II(b) clinical trial for Saroglitazar Magnesium in metabolic dysfunction-associated steatohepatitis (MASH). The trial, announced on August 31, 2026, met its primary endpoint.
Trial outcome and primary endpoint
The liver biopsy-driven study enrolled 189 subjects randomized in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg, or placebo over a treatment period of 52 weeks. The trial successfully achieved its main goal of resolving steatohepatitis without increasing fibrosis, a key benchmark in liver disease clinical research. The treatment difference was recorded at 26.5%.
In addition to the primary endpoint, the study demonstrated encouraging findings across key secondary and exploratory endpoints. These included improvements in liver histology parameters, steatosis, inflammation, and ballooning assessments.
Key highlights
- Drug candidate: Saroglitazar Mg
- Trial phase: Phase II(b)
- Disease area: MASH (metabolic dysfunction-associated steatohepatitis)
- Primary endpoint met: Resolution of steatohepatitis without worsening fibrosis
- Treatment difference: 26.5%
| Parameter | Details |
|---|---|
| Trial name | EVIDENCES-X |
| Trial phase | Phase II(b) |
| Drug | Saroglitazar Mg |
| Disease indication | MASH |
| Primary endpoint | Resolving steatohepatitis without increasing fibrosis |
| Outcome | Met |
| Treatment difference | 26.5% |
| Subjects enrolled | 189 |
| Treatment duration | 52 weeks |
The successful achievement of the primary endpoint marks a significant development in Zydus' clinical programme for MASH, a liver condition with limited approved therapeutic options. The results add to the body of evidence being generated for Saroglitazar Mg in the ongoing development programme.
Leadership and regulatory context
The trial was led by Prof. Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine, and Prof. Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University, as co-Principal Investigators.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, stated that the successful completion marks an important milestone in the MASH development programme. He noted that these results reinforce the therapeutic potential of Saroglitazar Mg and the company's commitment to developing innovative treatment options for patients suffering from chronic liver diseases.
Saroglitazar Mg was approved by the Drug Controller General of India (DCGI) for the treatment of MASH and MASLD in India in 2020. It remains an investigational compound in the United States and has not yet been approved by the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH and MASLD.
Further details from the trial will be presented at the upcoming Liver Congress and submitted for publication in a peer-reviewed medical journal.
What is the projected timeline for Zydus Lifesciences to initiate Phase III clinical trials for Saroglitazar Mg in the US and European markets?
How might the 26.5% treatment difference impact Saroglitazar's competitive positioning against other late-stage MASH therapies currently in development?
Will Zydus pursue a standalone FDA approval for Saroglitazar or seek strategic partnerships with major pharmaceutical companies for global commercialization?
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