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Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD (Ertu-NASH)

Primary Purpose

Liver Fat, Liver Fibrosis, Glycemic Control

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ertugliflozin 5 mg, 15mg
Sponsored by
Getz Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient able to provide written informed consent Adult males & females between 18 to 65 years SGLT2i and insulin naïve patients BMI >23 Kg/m2 HbA1C % ≥ 6.5 to 10 Documented hepatic steatosis or fatty liver disease on Ultrasound Patient with Type II Diabetes Mellitus Exclusion Criteria: History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study. Pioglitazone use in the past 6 months History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study. History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study. History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome) History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV History of recurrent UTIs and mycotic infection. Severely ill patients (who have high grade fever, sepsis or acute infection) Pregnant woman, lactating woman or planning pregnancy during study duration History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines). History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines. Severe hepatic impairment ( AST & ALT levels > 3 times upper limit normal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ertugliflozin

    Arm Description

    Ertugliflozin 5/15mg once daily with standard of care

    Outcomes

    Primary Outcome Measures

    Radiologic liver parameters
    Number of participants reported change in liver fat content from baseline, as quantified by fibroscan

    Secondary Outcome Measures

    HbA1c% levels compare with baseline in 6 months
    Efficacy
    Change in body weight compare with baseline in 6 months
    Body Weight
    Change in waist circumference compare with baseline in 6 months
    Waist Circumference
    Fibrosis 4 score levels compare with baseline in 6 months
    Fibrosis Scoring < 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, > 3.25 indicates Fibrosis stage 3-4
    Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months
    Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, < -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, > 0.676 indicates Fibrosis Stage 3-4
    Frequency of adverse events in 6 months
    Safety

    Full Information

    First Posted
    November 18, 2022
    Last Updated
    November 30, 2022
    Sponsor
    Getz Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05644717
    Brief Title
    Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
    Acronym
    Ertu-NASH
    Official Title
    Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease /Non-Alcoholic Steatohepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Getz Pharma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis & glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes, Waist Circumference, Tolerance

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ertugliflozin
    Arm Type
    Experimental
    Arm Description
    Ertugliflozin 5/15mg once daily with standard of care
    Intervention Type
    Drug
    Intervention Name(s)
    Ertugliflozin 5 mg, 15mg
    Intervention Description
    Ertugliflozin 5/15mg once daily in addition to standard of care
    Primary Outcome Measure Information:
    Title
    Radiologic liver parameters
    Description
    Number of participants reported change in liver fat content from baseline, as quantified by fibroscan
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    HbA1c% levels compare with baseline in 6 months
    Description
    Efficacy
    Time Frame
    up to 24 weeks
    Title
    Change in body weight compare with baseline in 6 months
    Description
    Body Weight
    Time Frame
    up to 24 weeks
    Title
    Change in waist circumference compare with baseline in 6 months
    Description
    Waist Circumference
    Time Frame
    up to 24 weeks
    Title
    Fibrosis 4 score levels compare with baseline in 6 months
    Description
    Fibrosis Scoring < 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, > 3.25 indicates Fibrosis stage 3-4
    Time Frame
    up to 24 weeks
    Title
    Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months
    Description
    Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, < -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, > 0.676 indicates Fibrosis Stage 3-4
    Time Frame
    up to 24 weeks
    Title
    Frequency of adverse events in 6 months
    Description
    Safety
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient able to provide written informed consent Adult males & females between 18 to 65 years SGLT2i and insulin naïve patients BMI >23 Kg/m2 HbA1C % ≥ 6.5 to 10 Documented hepatic steatosis or fatty liver disease on Ultrasound Patient with Type II Diabetes Mellitus Exclusion Criteria: History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study. Pioglitazone use in the past 6 months History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study. History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study. History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome) History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV History of recurrent UTIs and mycotic infection. Severely ill patients (who have high grade fever, sepsis or acute infection) Pregnant woman, lactating woman or planning pregnancy during study duration History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines). History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines. Severe hepatic impairment ( AST & ALT levels > 3 times upper limit normal
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Atiba Alvi, MBBS
    Phone
    03203200222
    Email
    atiba.alvi@getzpharma.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussain Abidi, MBBS
    Phone
    03201212986
    Email
    hussain.baqar@getzpharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umar Raja, MBBS
    Organizational Affiliation
    Shifa International Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29097281
    Citation
    Hu M, Phan F, Bourron O, Ferre P, Foufelle F. Steatosis and NASH in type 2 diabetes. Biochimie. 2017 Dec;143:37-41. doi: 10.1016/j.biochi.2017.10.019. Epub 2017 Oct 31.
    Results Reference
    background
    PubMed Identifier
    27212244
    Citation
    Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016 Sep;65(3):589-600. doi: 10.1016/j.jhep.2016.05.013. Epub 2016 May 17.
    Results Reference
    background
    PubMed Identifier
    29358469
    Citation
    Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care. 2018 Feb;41(2):372-382. doi: 10.2337/dc17-1902.
    Results Reference
    background
    PubMed Identifier
    29137912
    Citation
    Mantovani A, Zaza G, Byrne CD, Lonardo A, Zoppini G, Bonora E, Targher G. Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis. Metabolism. 2018 Feb;79:64-76. doi: 10.1016/j.metabol.2017.11.003. Epub 2017 Nov 11.
    Results Reference
    background
    PubMed Identifier
    23855299
    Citation
    Schuppan D, Schattenberg JM. Non-alcoholic steatohepatitis: pathogenesis and novel therapeutic approaches. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:68-76. doi: 10.1111/jgh.12212.
    Results Reference
    background
    PubMed Identifier
    25371775
    Citation
    Gusdon AM, Song KX, Qu S. Nonalcoholic Fatty liver disease: pathogenesis and therapeutics from a mitochondria-centric perspective. Oxid Med Cell Longev. 2014;2014:637027. doi: 10.1155/2014/637027. Epub 2014 Oct 13.
    Results Reference
    background

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    Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

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