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Trial record 64 of 343 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

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

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ClinicalTrials.gov Identifier: NCT03617263
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Zydus Discovery DMCC

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. 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease in Women With PCOS Drug: Saroglitazar Magnesium 4 mg Tablet Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium once daily in the morning before breakfast
Drug: Saroglitazar Magnesium 4 mg Tablet
Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.

Placebo Comparator: Placebo
Placebo tablet once daily in the morning before breakfast
Drug: Placebo
Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.




Primary Outcome Measures :
  1. Hepatic fat content [ Time Frame: 24 weeks ]
    Change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF


Secondary Outcome Measures :
  1. Liver enzymes/LFTs [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in liver enzymes/LFTs: ALT, AST, ALP,GGT, serum protein, albumin and total bilirubin.

  2. Insulin resistance [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in insulin resistance as measured by HOMA

  3. Markers of liver injury [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in markers of liver injury

  4. Liver fibrosis [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in fibrosis including CK-18, hs-CRP, and TNFα

  5. Liver stiffness [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in liver stiffness measured by transient elastography/FibroScan

  6. Controlled attenuation parameter [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in controlled attenuation parameter measured by transient elastography/ FibroScan

  7. BMI [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in BMI

  8. Waist circumference [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in waist circumference

  9. MRI-derived measures of total liver fat index (It will be calculated as the product of liver volume and the liver mean proton-density fat fraction across all liver segments) [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in MRI-derived measures of total liver fat index

  10. MRI-derived measures of total liver volume (Liver volume will be calculated after complete segmentation by summing the liver surface area at each segmented slice, and then multiplying this sum by individual slice thickness, in millilitres [mL]) [ Time Frame: 24 weeks ]
    Changes from baseline to week 24 in MRI-derived measures of total liver volume

  11. Lipid and lipoprotein levels [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in lipid and lipoprotein levels: TG, TC, HDL, LDL, sdLDL, VLDL, apolipoprotein A and apolipoprotein B

  12. SHBG level [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in SHBG level

  13. Ovarian function [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in ovarian function (Total testosterone, 17-hydroxyprogesterone, free testosterone, luteinizing hormone, follicle-stimulating hormone, LH-to-FSH ratio and estradiol)

  14. Free androgen index ( Total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by a constant, usually 100. The concentrations of testosterone and SHBG are normally measured in nanomols per liter. [ Time Frame: 12 and 24 weeks ]
    Changes from baseline to week 12 and week 24 in free androgen index

  15. Peak Plasma concentration [Cmax] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  16. Time to reach peak Plasma concentration [Tmax] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  17. Area under Plasma concentration vs. time curve till the last time point [AUC0-t] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  18. Area under Plasma concentration vs. time curve extrapolated to the infinity (AUC0-∞) after first dose (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  19. Area under plasma concentration vs. time curve in a 24 h dosing interval (AUCtau) after first dose (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  20. Elimination rate constant [Kel] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  21. Elimination half-life [tHalf] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  22. Apparent Volume of distribution [Vd/F] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  23. Apparent Clearance [CL/F] (For Single Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  24. Peak Plasma concentration [Cmax,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  25. Time to reach peak Plasma concentration [Tmax,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  26. Area under plasma concentration vs. time curve in a 24 h dosing interval (AUCtau) after last dose (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  27. Elimination rate constant [Kel,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  28. Elimination half-life [thalf,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  29. Apparent Volume of distribution [Vd/F,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  30. Apparent Clearance [CL/F,ss] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  31. Minimal or Trough plasma concentration [Cmin] (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  32. Fluctuation index (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

  33. Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose) (For Multiple Dose) [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617263


Contacts
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Contact: Farheen Shaikh +971-43998280 ext 105 farheen.arifahmed@zydusdiscovery.ae
Contact: Deven Parmar, MD, FACP, FCP +971-43998280 ext 105 deven.parmar@zydusdiscovery.ae

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Yanin Tab Srisengfa         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Regina Weber         
Mexico
Centro de Investigación Medico Biológica y Terapia Avanzada SC (CIMBYTA) Not yet recruiting
Guadalajara, Jalisco, Mexico, 44130
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Not yet recruiting
Monterrey, Nuevo León, Mexico, 64460
UBAM Unidad Biomédica Avanzada Monterrey Not yet recruiting
Monterrey, Nuevo León, Mexico, 64460
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. Not yet recruiting
Culiacán, Sinaloa, Mexico, 80230
Medical Care and Research S.A. de C.V. Not yet recruiting
Mérida, Yucatán, Mexico, 97070
CEMDEC S.A. de C.V. (Centero Mexicana Desarrollo de Estudios Clinicos) Recruiting
Ciudad de mexico, Mexico, 06100
Sponsors and Collaborators
Zydus Discovery DMCC
Investigators
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Study Director: Deven Parmar, MD, FACP, FCP Zydus Discovery DMCC

Publications:
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Responsible Party: Zydus Discovery DMCC
ClinicalTrials.gov Identifier: NCT03617263     History of Changes
Other Study ID Numbers: SARO.17.009
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zydus Discovery DMCC:
NAFLD
PCOS
Saroglitazar Magnesium

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases