NCT05011305

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects With Nonalcoholic Steatohepatitis and Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Detailed description

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.

Conditions

• Nonalcoholic Steatohepatitis
• Fibrosis

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 2 mg	Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
DRUG	Saroglitazar Magnesium 4 mg	Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
DRUG	Placebo	Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

Timeline

• Start date: 2021-08-18
• Primary completion: 2025-09-12
• Completion: 2025-09-12
• First posted: 2021-08-18
• Last updated: 2025-10-24

Locations

129 sites across 4 countries: United States, Argentina, Puerto Rico, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study