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A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis (NASH)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 16, 2026
NCT ID
NCT03863574
Status
COMPLETED
Phase
Phase 2
Sponsor
Zydus Therapeutics Inc.
Executive brief
Investment-Ready Snapshot
Saroglitazar Magnesium is being evaluated for its efficacy in treating Non-alcoholic Steatohepatitis (NASH), a condition with increasing prevalence and limited treatment options. The market for NASH therapeutics is projected to grow significantly, driven by rising obesity rates and increasing awareness of liver diseases. Zydus Therapeutics Inc. is positioned to capture market share if Saroglitazar demonstrates superior efficacy and safety compared to existing therapies. Competitive landscape includes other investigational drugs targeting NASH, necessitating robust clinical data to differentiate Saroglitazar. Diligence should focus on regulatory pathways and potential market access strategies, particularly in regions with high NASH prevalence.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT03863574
Indication
Non Alcoholic Steatohepatitis
Modality
small molecule
Target
Dual PPAR alpha/gamma agonist
Intervention
Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, Placebos
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.