Actively Recruiting
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Led by Getz Pharma · Updated on 2025-03-21
164
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient able to provide written informed consent
- Adult males & females between 18 to 65 years
- SGLT2i and insulin naive patients
- BMI >23 Kg/m2
- HbA1C % 65 6.5 to 10
- Documented hepatic steatosis or fatty liver disease on Ultrasound
- Patient with Type II Diabetes Mellitus
You will not qualify if you...
- History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin within 3 months prior to enrollment
- Pioglitazone use in the past 6 months
- History of vitamin E use (400mg twice daily) within 3 months prior to enrollment
- History of anti-obesity medication or weight loss procedure within 3 months prior to enrollment
- History of uncontrolled Endocrine disorder requiring frequent dose adjustment
- History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma, or HIV
- History of recurrent urinary tract infections and mycotic infection
- Severely ill patients with high fever, sepsis, or acute infection
- Pregnant, lactating, or planning pregnancy during study
- History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids)
- History of active substance abuse (e.g. heroin, cocaine, amphetamines)
- Alcohol intake of 10 - 30 g/day within the previous year
- Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine, or amphetamines
- Severe hepatic impairment with AST & ALT levels > 3 times upper limit normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
North west general hospital
Peshawar, KPK, Pakistan
Actively Recruiting
Research Team
M
Muhammad Nabeed Tahir, MBBS
CONTACT
J
Jahanzeb Kamal Khan, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here