Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
NCT ID: NCT05644717
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
164 participants
INTERVENTIONAL
2023-03-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ertugliflozin
Ertugliflozin 5/15mg once daily with standard of care
Ertugliflozin 5 mg, 15mg
Ertugliflozin 5/15mg once daily in addition to standard of care
Interventions
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Ertugliflozin 5 mg, 15mg
Ertugliflozin 5/15mg once daily in addition to standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Getz Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Umar Raja, MBBS
Role: PRINCIPAL_INVESTIGATOR
Shifa International Hospital
Locations
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North west general hospital
Peshawar, KPK, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Arshad Hussain, M.B.B.S
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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GTZ_DM_007_22
Identifier Type: -
Identifier Source: org_study_id
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