Summary

for females ages 18-45 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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. 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.

Official Title

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)

Keywords

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

Eligibility

You can join if…

Open to females ages 18-45

  • 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).
  • 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.

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
    Culiacán Sinaloa 80230 Mexico
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" not yet accepting patients
    Monterrey Nuevo León 64460 Mexico
  • UBAM Unidad Biomédica Avanzada Monterrey
    Monterrey Nuevo León 64460 Mexico
  • Centro de Investigación Medico Biológica y Terapia Avanzada SC (CIMBYTA)
    Guadalajara Jalisco 44130 Mexico

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Zydus Discovery DMCC
ID
NCT03617263
Phase
Phase 2
Study Type
Interventional
Last Updated
August 16, 2018