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Trial record 80 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

Safety, Tolerability and Efficacy of Saroglitazar Magnesium 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (EVIDENCES VIII)

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ClinicalTrials.gov Identifier: NCT03639623
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Zydus Discovery DMCC

Brief Summary:
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD as assessed by MRI-PDFF and MRE. The study will be conducted over a period of up to 33 weeks and will include 5 weeks screening, a 24 week treatment period and 4 week follow-up period. The primary end point of the study is to assess the safety of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD over 24 weeks of treatment.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease in Liver Transplant Recipients Drug: Saroglitazar Magnesium 4 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A, Single Center, Open-label, Single-arm, 24-week Study to Evaluate the Safety, Tolerability and Efficacy of Saroglitazar Magnesium 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast
Drug: Saroglitazar Magnesium 4 mg
All subjects will receive Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast




Primary Outcome Measures :
  1. Number of participants with adverse events assessed by CTCAE [ Time Frame: 24 weeks ]
    Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)


Secondary Outcome Measures :
  1. Hepatic fat [ Time Frame: 24 weeks ]
    Changes in hepatic fat as determined by MRI-PDFF and MRE from baseline to end-of-treatment (EOT)

  2. Metabolic flexibility [ Time Frame: 24 weeks ]
    Changes in metabolic flexibility from baseline to EOT

  3. Frequently sampled intravenous glucose tolerance test (Insulin resistance marker) [ Time Frame: 24 weeks ]
    Changes in frequently sampled intravenous glucose tolerance test (FSIVGTT) from baseline to EOT

  4. Glycosylated hemoglobin (Insulin resistance marker) [ Time Frame: 24 weeks ]
    Changes in glycosylated hemoglobin (HbA1c) from baseline to EOT

  5. Fructosamine (Insulin resistance marker) [ Time Frame: 24 weeks ]
    Changes in fructosamine from baseline to EOT

  6. Serum liver enzymes [ Time Frame: 24 weeks ]
    Changes in serum liver enzymes from baseline to EOT

  7. Serum lipids [ Time Frame: 24 weeks ]
    Changes in serum lipids from baseline to EOT

  8. Small dense low-density lipoprotein (Atherogenic lipoprotein) [ Time Frame: 24 weeks ]
    Changes in small dense low-density lipoprotein (sdLDL) from baseline to EOT

  9. LDL size and concentration (Atherogenic lipoprotein) [ Time Frame: 24 weeks ]
    Changes in LDL size and concentration from baseline to EOT

  10. Very low-density lipoprotein (Atherogenic lipoprotein) [ Time Frame: 24 weeks ]
    Changes in subtypes of very low-density lipoprotein (VLDL) from baseline to EOT

  11. High-density lipoprotein (Atherogenic lipoprotein) [ Time Frame: 24 weeks ]
    Changes in high-density lipoprotein (HDL) from baseline to EOT

  12. Quality of life (SF-36 Health Survey) [ Time Frame: 24 weeks ]
    Change in Quality of life score from baseline to EOT

  13. Peak plasma concentration [Cmax] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  14. Time to reach peak plasma concentration [Tmax] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  15. Area under plasma concentration vs. time curve till the last time point [AUC0-t] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  16. Area under plasma concentration vs. time curve extrapolated to the infinity [AUC0-∞] after first dose [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first dose

  17. Area under plasma concentration vs. time curve in a 24 h dosing interval [AUCtau] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  18. Elimination rate constant [λz] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  19. Elimination half-life [t1/2] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  20. Apparent volume of distribution [Vd/F] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  21. Apparent clearance [CL/F] [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and last dose

  22. Minimal or trough plasma concentration [Cmin] -for last dose only [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following last dose

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

  24. Fluctuation index [ Time Frame: 24 weeks ]
    Pharmacokinetics of Saroglitazar following first and 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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to give written informed consent.
  • Males or females, 18 to 75 years of age.
  • Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment.
  • The presence of NAFLD determined by MRI-PDFF prior to enrollment.
  • Patients with ≤20% variance in the levels of ALT, AST, ALP and total bilirubin between Visit 1 and Visit 1.1.
  • History of medical compliance with immunosuppression.
  • Female subjects of non-child bearing potential or on highly effective contraception. For male subjects with female partners of childbearing potential, willing to follow highly effective contraception measures during the study, either by the male participant or his female partner or both.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Patient with abnormal transaminases due to secondary intercurrent illness.
  • Patients with bile duct strictures.
  • Other causes of chronic liver disease after liver transplantation including autoimmune, viral, and alcoholic liver disease.
  • Graft cirrhosis as defined by:

    1. Cirrhosis on historical liver biopsy.
    2. Evidence of cirrhosis on imaging including portal venous collaterals.
    3. Prior history of decompensated liver disease including ascites, hepatic encephalopathy or variceal bleeding.
    4. Evidence of esophageal varices on prior endoscopy.
  • Body mass index (BMI) <18 kg/m².
  • Subjects with change in body weight >5% in the 3 months prior to enrollment.
  • Subjects requiring corticosteroid or anticoagulation therapy.
  • History of myopathies or evidence of active muscle diseases.
  • Unstable cardiovascular disease.
  • History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection.
  • Active malignancy post-liver transplantation.
  • History of malignancy in the past 5 years and/or active neoplasm.
  • History of chronic rejection of liver transplant graft.
  • Acute cellular rejection of liver transplant graft within the past 6 months.
  • Evidence of Acute cellular rejection (ACR) or chronic rejection (CR) or alternative etiologies to NAFLD.
  • Poorly controlled diabetes as defined by an HbA1c >8.5% within the past 6 months.
  • History of excessive alcohol intake.

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): NCT03639623


Contacts
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Contact: Deven Parmar, MD FCP +1-609-730-1900 ext 407 deven.parmar@zydusdiscovery.ae
Contact: Neelakant Krishnan, BDS PGDCR +1-609-730-1900 ext 222 Neelakant.Krishnan@zyduscadila.com

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Sherry Boyett, RN    804-828-5434      
Sponsors and Collaborators
Zydus Discovery DMCC
Investigators
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Study Director: Deven Parmar, MD FCP Zydus Discovery DMCC

Publications:
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Responsible Party: Zydus Discovery DMCC
ClinicalTrials.gov Identifier: NCT03639623     History of Changes
Other Study ID Numbers: SARO.17.010
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 7, 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:
Peroxisome proliferator-activated receptors
NAFLD
NASH
Post Transplant Metabolic Syndrome

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