drugset
drugset / Trial / NCT05872269

A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

NCT05872269 ↗

Phase 4 Unknown 1500 enrolled Zydus Lifesciences Limited
NaSingle-groupOpen-labelTreatment

Summary

A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

Timeline

Start
2023-07-20
Primary completion
2025-01-10
Completion
2025-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Saroglitazar Small molecule 4 mg Oral

Indications

hyperlipidemia metabolic dysfunction-associated steatotic liver disease metabolic syndrome X obesity disorder type 2 diabetes mellitus