Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGetz Pharma
About this trial
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 criteria
Qualifiers
Patient able to provide written informed consent
Adult males & females between 18 to 65 years
SGLT2i and insulin naïve patients
BMI >23 Kg/m2
Disqualifiers
History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.
Pioglitazone use in the past 6 months
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.
Trial design
Treatments tested in this trial
- Ertugliflozin 5 mg, 15mg
Treatment groups
164 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov