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

Getz Pharma

Status and phase

Enrolling

Phase 4

Conditions

Waist Circumference

Glycemic Control

Tolerance

Liver Fibrosis

Liver Fat

Body Weight Changes

Treatments

Drug: Ertugliflozin 5 mg, 15mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05644717

GTZ_DM_007_22

Details and patient eligibility

About

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)

Enrollment

164 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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