At a glance
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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)
In Brief
A Phase 2 clinical trial evaluating Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, and 1 other intervention for Non Alcoholic Steatohepatitis. Completed, enrolled 16 participants across 6 sites.
Detailed Summary
This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local regulatory authority.
Study Details
Timeline
Interventions
Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks.
Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.
Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.