Liver Fibrosis Clinical Trial
— Ertu-NASHOfficial 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
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)
Status | Not yet recruiting |
Enrollment | 164 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Getz Pharma |
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiologic liver parameters | Number of participants reported change in liver fat content from baseline, as quantified by fibroscan | up to 24 weeks | |
Secondary | HbA1c% levels compare with baseline in 6 months | Efficacy | up to 24 weeks | |
Secondary | Change in body weight compare with baseline in 6 months | Body Weight | up to 24 weeks | |
Secondary | Change in waist circumference compare with baseline in 6 months | Waist Circumference | up to 24 weeks | |
Secondary | 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 | up to 24 weeks | |
Secondary | 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 |
up to 24 weeks | |
Secondary | Frequency of adverse events in 6 months | Safety | up to 24 weeks |
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