Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
NCT ID: NCT03617263
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2019-02-12
2024-10-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium once daily in the morning before breakfast
Saroglitazar Magnesium 4 mg Tablet
Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.
Placebo
Placebo tablet once daily in the morning before breakfast
Placebo
Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
Interventions
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Saroglitazar Magnesium 4 mg Tablet
Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.
Placebo
Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Zydus Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deven Parmar, MD
Role: STUDY_DIRECTOR
Zydus Therapeutics Inc.
Locations
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Zydus US005
Chandler, Arizona, United States
Zydus US004
Panorama City, California, United States
Zydus US002
San Francisco, California, United States
Zydus US008
Aurora, Colorado, United States
Zydus US010
Miami, Florida, United States
Zydus US001
Indianapolis, Indiana, United States
Zydus US011
Morehead City, North Carolina, United States
Zydus US003
Marion, Ohio, United States
Zydus US015
Hershey, Pennsylvania, United States
Zydus US014
Philadelphia, Pennsylvania, United States
Zydus US013
Austin, Texas, United States
Zydus US007
San Antonio, Texas, United States
Zydus US009
San Antonio, Texas, United States
Zydus MX006
Guadalajara, Jalisco, Mexico
Zydus MX001
Monterrey, Nuevo León, Mexico
Zydus MX002
Monterrey, Nuevo León, Mexico
Zydus MX005
Culiacán, Sinaloa, Mexico
Zydus MX004
Mérida, Yucatán, Mexico
Zydus MX003
Mexico City, , Mexico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SARO.17.009
Identifier Type: -
Identifier Source: org_study_id