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A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Primary Purpose

NAFLD, Obesity, Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Saroglitazar
Sponsored by
Zydus Lifesciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring Real World Evidence Study

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients aged ≥18 years Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time) Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol . Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening: Liver stiffness through transient elastography, an LSM ≥8 kPa OR Serum ALT ≥45 U/L Exclusion Criteria: Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study. Pregnant or breast feeding females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Saroglitazar 4 mg tablets

    Arm Description

    Oral (once daily ) during 364 days/52 weeks of treatment period.

    Outcomes

    Primary Outcome Measures

    Change in liver stiffness
    liver stiffness measurement performed by transient elastography
    Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

    Secondary Outcome Measures

    Change in TG, HDL-C, LDL-C and non HDL-C levels
    Change in serum ALT value
    Change in serum AST value
    Change in serum ALP value
    Change in body weight
    Change in BMI

    Full Information

    First Posted
    May 13, 2023
    Last Updated
    May 25, 2023
    Sponsor
    Zydus Lifesciences Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05872269
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
    Official Title
    A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2023 (Anticipated)
    Primary Completion Date
    January 10, 2025 (Anticipated)
    Study Completion Date
    June 10, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zydus Lifesciences Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
    Detailed Description
    The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD). Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD, Obesity, Type 2 Diabetes, Dyslipidemias, Metabolic Syndrome
    Keywords
    Real World Evidence Study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Saroglitazar 4 mg tablets
    Arm Type
    Experimental
    Arm Description
    Oral (once daily ) during 364 days/52 weeks of treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Saroglitazar
    Intervention Description
    4 Mg Oral Tablet
    Primary Outcome Measure Information:
    Title
    Change in liver stiffness
    Description
    liver stiffness measurement performed by transient elastography
    Time Frame
    Baseline to Week 52
    Title
    Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
    Time Frame
    Baseline to Week 52
    Secondary Outcome Measure Information:
    Title
    Change in TG, HDL-C, LDL-C and non HDL-C levels
    Time Frame
    Baseline to Week 24 and Week 52
    Title
    Change in serum ALT value
    Time Frame
    Baseline to Week 24 and Week 52
    Title
    Change in serum AST value
    Time Frame
    Baseline to Week 24 and Week 52
    Title
    Change in serum ALP value
    Time Frame
    Baseline to Week 24 and Week 52
    Title
    Change in body weight
    Time Frame
    Baseline to Week 24 and Week 52
    Title
    Change in BMI
    Time Frame
    Baseline to Week 24 and Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female patients aged ≥18 years Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time) Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol . Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening: Liver stiffness through transient elastography, an LSM ≥8 kPa OR Serum ALT ≥45 U/L Exclusion Criteria: Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study. Pregnant or breast feeding females
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr Maulik Doshi, DM
    Phone
    02717-665555
    Ext
    279
    Email
    Maulik.Doshi@zyduslife.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Deven Parmar, MD,FCP
    Organizational Affiliation
    Zydus Therapeutics Inc.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

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