Skip to content
TrialMatch
Sign up
Recruiting Phase 4

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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)

Condition
Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes, Waist Circumference, Tolerance
Tested
Ertugliflozin 5 mg, 15mg
Sponsor
Getz Pharma

Who can join

Age
18 to 65 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 65 years
  • Study condition: Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes, Waist Circumference, Tolerance
  • 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 14

  • 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

Where

1 site, 1 recruiting

North west general hospital

Peshawar, KPK, Pakistan

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.