Effects of Ertugliflozin on liver fat and diabetes control in patients with fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, prospective, single-arm, multicenter study designed to evaluate the effects of Ertugliflozin on liver fat, liver fibrosis, and glycemic control in adults with Type 2 Diabetes Mellitus who also have Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). Participants will receive either 5 mg or 15 mg of Ertugliflozin. The study aims to assess changes in liver fat and fibrosis, as well as improvements in glycemic control and body weight. The trial will include patients who meet specific eligibility criteria related to their diabetes and liver health.

Why it matters

Who can join: the full rules

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

Where it's running

• North west general hospital
  Peshawar, Kpk, Pakistan Recruiting

Study contacts

• Principal investigator: Umar Raja, MBBS — Shifa International Hospital
• Study coordinator: Muhammad Nabeed Tahir, MBBS
• Email: nabeedtahir@getzpharma.com
• Phone: +923015376299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.