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

Phase 2 Terminated 60 enrolled Zydus Therapeutics Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2019-02-12
Primary completion: 2024-10-28
Completion: 2024-10-28

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision”

registry analysis (superiority test); Saroglitazar Magnesium 4 mg vs Placebo; p = 0.0613; ANCOVA NCT03617263 ↗

Publications

Background Kelley CE, Brown AJ, Diehl AM, Setji TL. Review of nonalcoholic fatty liver disease in women with polycystic ovary syndrome. World J Gastroenterol. 2014 Oct 21;20(39):14172-84. doi: 10.3748/wjg.v20.i39.14172.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Saroglitazar	Small molecule	4 mg	Oral