Study of Ertugliflozin Effects on Liver Fat, Liver Scarring, and Blood Sugar Control in Adults with Type 2 Diabetes and Fatty Liver Disease

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.

Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD