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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Pakistan
North west general hospital
RECRUITING
Peshawar
Contact Information
Primary
Muhammad Nabeed Tahir, MBBS
nabeedtahir@getzpharma.com
+923015376299
Backup
Jahanzeb Kamal Khan, MBBS
jahanzeb.kamal@getzpharma.com
+923201212945
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 164
Treatments
Experimental: Ertugliflozin
Ertugliflozin 5/15mg once daily with standard of care
Related Therapeutic Areas
Sponsors
Leads: Getz Pharma