Steatosis and NASH in type 2 diabetes.
Mengyue Hu, Franck Phan, Olivier Bourron...
https://pubmed.ncbi.nlm.nih.gov/29097281Actively Recruiting
Phase 4
Age: 18Years - 65Years
All Genders
ID05644717
Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Adults With Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis
Led by Getz Pharma · Updated on 2025-03-21
164
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Ertugliflozin on liver fat, liver fibrosis, and blood sugar control in adults with Type 2 Diabetes Mellitus (T2DM) who also have Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). This open-label, prospective, single-arm, multicenter study focuses on how this drug impacts these liver conditions and glycemic control. The study is sponsored by Getz Pharma and is conducted as a Phase 4 clinical trial. Participants receive Ertugliflozin once daily in doses of 5 mg or 15 mg alongside their standard care treatments. The study does not include a placebo group or randomization. The treatment period lasts up to 24 weeks, during which liver-related parameters, blood sugar levels, body weight, waist circumference, and fibrosis scores are monitored to assess changes. Throughout the study, participants will undergo various assessments including radiologic evaluations of the liver, blood tests to measure HbA1c and fibrosis scores, and physical measurements such as waist circumference and body weight. Adverse events will be tracked for safety monitoring. The total participation duration is up to 24 weeks, allowing researchers to observe the effects of Ertugliflozin on liver health and glucose control over this period.
CONDITIONS
Brief Title
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Adult males and females aged 18 to 65 years
- Patients who have not used SGLT2 inhibitors or insulin before
- Body mass index (BMI) greater than 23 kg/m2
- HbA1c percentage between 6.5 and 10
- Documented fatty liver disease confirmed by ultrasound
- Diagnosed with Type 2 Diabetes Mellitus
You will not qualify if you...
- Use of SGLT2 inhibitors, GLP-1 agonists, or insulin within 3 months before enrollment
- Use of pioglitazone within 6 months before enrollment
- Use of vitamin E (400mg twice daily) within 3 months before enrollment
- Use of anti-obesity medication or weight loss surgery within 3 months before enrollment
- Uncontrolled endocrine disorders such as hypothyroidism or Cushing's syndrome
- History of liver diseases including viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, or HIV
- History of recurrent urinary tract or fungal infections
- Severe illness including high fever, sepsis, or acute infection
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of drug-induced liver disease from certain medications
- History of active substance abuse including heroin, cocaine, amphetamines, or cannabinoid-derived substances
- Alcohol intake of 10 to 30 grams per day within the previous year
- Active substance abuse including acetaminophen overuse, hashish, tobacco, heroin, cocaine, or amphetamines
- Severe liver impairment with AST and ALT levels more than three times the upper limit of normal liver enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 24 weeks
Participants take Ertugliflozin 5mg or 15mg once daily along with standard care to manage Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis.
Trial Site Locations
Total: 1 location
1
North west general hospital
Peshawar, KPK, Pakistan
Actively Recruiting
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Research Team
M
Muhammad Nabeed Tahir, MBBS
J
Jahanzeb Kamal Khan, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis.
Giovanni Targher, Christopher D Byrne, Amedeo Lonardo...
https://pubmed.ncbi.nlm.nih.gov/27212244Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis.
Alessandro Mantovani, Christopher D Byrne, Enzo Bonora...
https://pubmed.ncbi.nlm.nih.gov/29358469Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis.
Alessandro Mantovani, Gianluigi Zaza, Christopher D Byrne...
https://pubmed.ncbi.nlm.nih.gov/29137912Non-alcoholic steatohepatitis: pathogenesis and novel therapeutic approaches.
Detlef Schuppan, Jörn M Schattenberg
https://pubmed.ncbi.nlm.nih.gov/23855299Nonalcoholic Fatty liver disease: pathogenesis and therapeutics from a mitochondria-centric perspective.
Aaron M Gusdon, Ke-Xiu Song, Shen Qu
https://pubmed.ncbi.nlm.nih.gov/25371775