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Search / Trial NCT05644717

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

Launched by GETZ PHARMA · Nov 30, 2022

Trial Information

Current as of January 21, 2025

Unknown status

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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

Trial Officials

Umar Raja, MBBS

Principal Investigator

Shifa International Hospital

About Getz Pharma

Getz Pharma is a leading pharmaceutical company dedicated to improving global health through the development and commercialization of innovative therapies. With a strong focus on research and development, Getz Pharma specializes in a diverse range of therapeutic areas, including cardiology, oncology, and infectious diseases. The company is committed to high standards of quality and compliance in its clinical trials, ensuring that its products meet rigorous safety and efficacy criteria. Through strategic partnerships and a robust pipeline, Getz Pharma aims to address unmet medical needs and enhance patient outcomes worldwide.

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Timeline

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Trial launched

Trial updated

Estimated completion

Not reported

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