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

Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Age Range:18 - 45
Start Date:December 4, 2018
End Date:January 2020
Contact:Farheen Shaikh

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A Phase 2A, Double-blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablet Versus Placebo for Treating Nonalcoholic Fatty Liver Disease (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.

Inclusion Criteria:

- 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).

- 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.

Exclusion Criteria:

- 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

- 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

- 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.
We found this trial at
San Francisco, California 94143
San Francisco, CA
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Indianapolis, Indiana 46202
Indianapolis, IN
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