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

NCT03617263 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-18

Study results available
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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.

Conditions

  • Non-alcoholic Fatty Liver Disease in Women With PCOS

Interventions

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.

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven Parmar, MD · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2024-10-28
Completion
2024-10-28
FDA Drug
Yes

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617263 on ClinicalTrials.gov