NCT05644717RecruitingPhase 4
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
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
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- First submitted
- 18 Nov 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Getz Pharma
- NCT number
- NCT05644717
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 164
- From 1 Mar 2023 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.
- 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.
- Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year
Other illness
- 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)
- History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).
Lab values
- History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests
- Severe hepatic impairment ( AST \& ALT levels \> 3 times upper limit normal
Other
- Pioglitazone use in the past 6 months
- Pregnant woman, lactating woman or planning pregnancy during study duration
- Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North west general hospital Coordinator of this site? Confirm its status | Peshawar | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.