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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 : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Zydus Therapeutics Inc.

Study Description
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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.

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

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arms and Interventions
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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.
Other Name: Not any
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.
Other Name: Not any


Outcome Measures
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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


Eligibility Criteria
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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).
  • 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:

  • 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.
Contacts and Locations
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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 +1 6094534751 fshaikh@zydustherapeutics.com

Locations
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United States, Arizona
Dr.Anita Kohli Recruiting
Chandler, Arizona, United States, 85224
Contact: Mari Johnson       johnsonmari87@gmail.com   
United States, California
Dr.Robert Allen Jenders Recruiting
Panorama City, California, United States, 91402
Contact: Vanessa Delgado    818-532-6880 ext 3109    vanessa.delgado@nritrials.com   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Yanin T Srisengfa    415-502-3725    yanin.srisengfa@ucsf.edu   
Contact: Rayshawnda Davis    415-502-3725    rayshawnda.davis@ucsf.edu   
Principal Investigator: Dr. Monika Sarkar         
United States, Colorado
Dr.Melanie Cree Green Recruiting
Aurora, Colorado, United States, 80045
Contact: Wesley Pendleton, MS, RDN    720-777-5974    Wesley.Pendleton@childrenscolorado.org   
Contact: Nicola Haakonsen       NICOLA.HAAKONSEN@CUANSCHUTZ.EDU   
United States, Florida
Dr. Yaneicy Gonzalez Rojas Recruiting
Miami, Florida, United States, 33125
Contact: Laylien Souza    305-702-0024    souza@optimusu.com   
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Regina Weber    317-278-6266    reginaw@iu.edu   
Principal Investigator: Dr. Niharika Samala         
United States, North Carolina
Dr. KATHRYN JEAN LUCAS Recruiting
Morehead City, North Carolina, United States, 28557
Contact: Ashley Bissette, BSC       ashley.bissette@lucasresearch.org   
United States, Texas
Dr. Nicole Loo Recruiting
San Antonio, Texas, United States, 78215
Contact: Bertha Buan    210-253-3426    bbuan@txliver.com   
Dr. Mark Kipnes Recruiting
San Antonio, Texas, United States, 78229
Contact: Josette Negrete    210-614-8612 ext 1515    josette.negrete@dgdclinic.com   
Mexico
Centro de Investigación Medico Biológica y Terapia Avanzada SC (CIMBYTA) Active, not recruiting
Guadalajara, Jalisco, Mexico, 44130
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Active, not recruiting
Monterrey, Nuevo León, Mexico, 64460
UBAM Unidad Biomédica Avanzada Monterrey Active, not recruiting
Monterrey, Nuevo León, Mexico, 64460
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. Active, not recruiting
Culiacán, Sinaloa, Mexico, 80230
Medical Care and Research S.A. de C.V. Active, not recruiting
Mérida, Yucatán, Mexico, 97070
CEMDEC S.A. de C.V. (Centero Mexicana Desarrollo de Estudios Clinicos) Active, not recruiting
Ciudad de mexico, Mexico, 06100
Sponsors and Collaborators
Zydus Therapeutics Inc.
Investigators
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Study Director: Deven Parmar, MD Zydus Therapeutics Inc.
More Information
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Publications:

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Responsible Party: Zydus Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03617263    
Other Study ID Numbers: SARO.17.009
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Therapeutics Inc.:
NAFLD
PCOS
Saroglitazar Magnesium
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases