for females ages 18-45 (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Dr. Monika Sarkar
Headshot of Monika Sarkar
Monika Sarkar



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.

Official Title

Phase 2A, Double-blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Mg 4 mg Tablet Vs Placebo for Treating NAFLD in Women With Polycystic Ovary Syndrome (PCOS)


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. \

The study will be conducted over a period of up to 34 weeks and will include Screening (Days -28 to -7) Phase, a 24-week Treatment Phase following randomization on Day 1.

The primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF.


Non-alcoholic Fatty Liver Disease in Women With PCOS, NAFLD, PCOS, Saroglitazar Magnesium, Liver Diseases, Fatty Liver, Non-alcoholic Fatty Liver Disease, Saroglitazar Magnesium 4 mg Tablet, Saroglitazar Magnesium 4 mg


You can join if…

Open to females ages 18-45

  • Females, 18 to 45 years of age.
  • Previously confirmed diagnosis of PCOS:
    1. oligo-and/or anovulation;
    2. hyperandrogenism (clinical and/or biochemical);
    3. 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 CAN'T join 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.
  • History of myopathies or evidence of active muscle diseases.
  • History or current significant cardiovascular disease.
  • History of malignancy.
  • History of bladder disease.


  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Dr.Robert Allen Jenders accepting new patients
    Panorama City California 91402 United States

Lead Scientist at UCSF

  • Dr. Monika Sarkar
    My clinical focus is on women with liver disease, including pregnancy-related liver conditions and reproductive health. My research program is focused on the role of sex hormones in modulating liver disease in women.


accepting new patients
Start Date
Completion Date
Zydus Therapeutics Inc.
Phase 2 research study
Study Type
Expecting 90 study participants
Last Updated