NCT05872269

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD). Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

Conditions

• NAFLD
• Obesity
• Type 2 Diabetes
• Dyslipidemias
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Saroglitazar	4 Mg Oral Tablet

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-01-10
• Completion: 2025-06-10
• First posted: 2023-05-24
• Last updated: 2024-02-07

Locations

19 sites across 1 country: India