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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Getz Pharma
• Treatments: Ertugliflozin

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