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

NCT03617263 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SARO.17.009
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 19

Brief 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

Keywords

NAFLD; PCOS; Saroglitazar Magnesium

Outcome Measures

Primary Outcomes (1)

• Hepatic Fat Content

  Change in hepatic fat content from baseline following 24 weeks of treatment as measured by Magnetic Resonance Imaging-derived Proton Density-fat Fraction (MRI-PDFF)

  Baseline and Week 24

Secondary Outcomes (53)

• Liver Enzymes/Liver Function Tests

  Baseline, Week 12, and Week 24

• Liver Enzymes/Liver Function Tests

  Baseline, Week 12, and Week 24

• Liver Enzymes/Liver Function Tests

  Baseline, Week 12, and Week 24

• Liver Enzymes/Liver Function Tests

  Baseline, Week 12, and Week 24

• Liver Enzymes/Liver Function Tests

  Baseline, Week 12, and Week 24

Study Arms (2)

Saroglitazar Magnesium 4 mg

EXPERIMENTAL

Saroglitazar Magnesium once daily in the morning before breakfast

Drug: Saroglitazar Magnesium 4 mg Tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily in the morning before breakfast

Drug: Placebo

Interventions

Saroglitazar Magnesium 4 mg Tablet DRUG

Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.

Also known as: Not any

Saroglitazar Magnesium 4 mg

Placebo DRUG

Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.

Also known as: Not any

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females, 18 to 45 years of age.
• Previously confirmed diagnosis of PCOS:
• oligo-and/or anovulation;
• hyperandrogenism (clinical and/or biochemical);
• polycystic ovary morphology on ultrasonography
• Evidence of NAFLD within 6 months prior to the Screening Visit (Visit 1).
• Alanine transaminase ≥ 38 U/L at Visit 1. Visit 2 ALT must not increase \>30% from Visit 1.
• Hepatic fat fraction ≥10% by MRI-PDFF.
• Willingness to participate in the study.
• Ability to understand and give informed consent for participation.
• Woman who agrees to use the contraceptive methods.

You may not qualify if:

• Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
• Average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior to enrollment.
• Clinical, imaging, or histological evidence of cirrhosis.
• Patients who have used medications known to cause hepatic steatosis for more than 2 weeks in the past year.
• Prior bariatric surgery.
• Weight loss of more than 5% in the 3 months preceding screening.
• Severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness).
• Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator or formulation ingredients.
• Use of antidiabetic and lipid lowering medications if the dose is not stable for at least the 3 months preceding screening.
• Intake of Vitamin E (\>100 IU/day) or multivitamins containing Vitamin E (\>100 IU/day) 3 months before enrollment.
• Use of drugs with potential effect on NAFLD/NASH in the 3 months prior to screening.
• Illicit substance abuse within the past 12 months.
• Pregnant or breast feeding females.
• Women with known Cushing syndrome or hyperprolactinemia.
• Refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests.

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (19)

Zydus US005

Chandler, Arizona, 85224, United States

Location

Zydus US004

Panorama City, California, 91402, United States

Location

Zydus US002

San Francisco, California, 94143, United States

Location

Zydus US008

Aurora, Colorado, 80045, United States

Location

Zydus US010

Miami, Florida, 33125, United States

Location

Zydus US001

Indianapolis, Indiana, 46202, United States

Location

Zydus US011

Morehead City, North Carolina, 28557, United States

Location

Zydus US003

Marion, Ohio, 43302, United States

Location

Zydus US015

Hershey, Pennsylvania, 17033, United States

Location

Zydus US014

Philadelphia, Pennsylvania, 19104, United States

Location

Zydus US013

Austin, Texas, 78745, United States

Location

Zydus US007

San Antonio, Texas, 78215, United States

Location

Zydus US009

San Antonio, Texas, 78229, United States

Location

Zydus MX006

Guadalajara, Jalisco, 44130, Mexico

Location

Zydus MX001

Monterrey, Nuevo León, 64460, Mexico

Location

Zydus MX002

Monterrey, Nuevo León, 64460, Mexico

Location

Zydus MX005

Culiacán, Sinaloa, 80230, Mexico

Location

Zydus MX004

Mérida, Yucatán, 97070, Mexico

Location

Zydus MX003

Mexico City, 06100, Mexico

Location

Related Publications (1)

• 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.

  PMID: 25339805 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

saroglitazar; Tablets

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Deven Parmar
• Organization: Zydus Therapeutics Inc.

dparmar@zydustherapeutics.com

7324050886

Study Officials

• Deven Parmar, MD

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 6, 2018
• Study Start: February 12, 2019
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); ME (6)