NCT03617263

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

Phase 2A, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Mg 4 mg Tablet Vs Placebo for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

Detailed description

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS. The study will be conducted over a period of up to 34 weeks and will include Screening (Days -28 to -7) Phase, a 24-week Treatment Phase following randomization on Day 1. The primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF.

Conditions

• Non-alcoholic Fatty Liver Disease in Women With PCOS

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 4 mg Tablet	Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.
DRUG	Placebo	Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.

Timeline

• Start date: 2019-02-12
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2018-08-06
• Last updated: 2025-12-18
• Results posted: 2025-12-18

Locations

19 sites across 2 countries: United States, Mexico

Regulatory

• FDA-regulated drug study