Effects of Ertugliflozin on liver fat and diabetes control in patients with fatty liver disease
Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease /Non-Alcoholic Steatohepatitis
This study is testing if the medication Ertugliflozin can help adults with Type 2 Diabetes and fatty liver disease reduce liver fat and improve their blood sugar control.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Getz Pharma Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Peshawar, KPK) |
| Trial ID | NCT05644717 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with Type 2 Diabetes Mellitus and documented hepatic steatosis.
Not a fit: Patients with a history of certain liver diseases or those who have used specific diabetes medications recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of liver fat and diabetes in patients with NAFLD/NASH.
How similar studies have performed: Other studies have shown promise in using SGLT2 inhibitors for managing liver fat and diabetes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Peshawar, KPK
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.