Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor
in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).
Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG)
(primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose
production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory
analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with
treatment will be performed.