TerminatedPhase 2

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

Stopped: Sponsor Decision

United States60 participantsStarted 2019-02-12

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. oligo-and/or anovulation;
✓. hyperandrogenism (clinical and/or biochemical);
✓. polycystic ovary morphology on ultrasonography

What they're measuring

Hepatic Fat Content

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT03617263

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-28

Results submitted2025-10-23

View on ClinicalTrials.gov More Non-alcoholic Fatty Liver Disease in Women With PCOS trials