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Criteria:\n\n1. Male or female, aged ≥ 18 years at the time of signing informed consent\n2. Diagnosis of NASH, based on histology or cT1≥875ms assessed by LiverMultiScan or cT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed by MRI-PDFF at screening\n3. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and\u002For dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months\n4. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.\n\nExclusion Criteria:\n\nLiver-related:\n\n1. Documented causes of chronic liver disease other than NASH\n2. Histologically documented liver cirrhosis (fibrosis stage F4)\n3. History or current diagnosis of hepatocellular carcinoma (HCC)\n4. History of or planned liver transplant\n5. Documented history of human immunodeficiency virus (HIV) infection\n6. ALT or AST \\> 5 × upper limit of normal (ULN)\n7. Abnormal liver function as defined by central laboratory evaluation:\n\n   Albumin \\\u003C LLN INR ≥ 1.3 (unless patient is on anticoagulants) Total bilirubin level ≥ 1.5 mg\u002FdL (25.7 µmol\u002FL) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg\u002FdL (7.7 μmol\u002FL) )\n8. Hemoglobin \\\u003C 110 g\u002FL (11 g\u002FdL) for females and \\\u003C 120 g\u002FL (12 g\u002FdL) for males\n9. WBC \\\u003C LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator\n10. Platelet count \\\u003C 140,000\u002FµL\n11. ALP \\> 2 × ULN\n12. Patient currently receiving any approved treatment for NASH or obesity\n13. Current or recent history (\\\u003C 5 years) of significant alcohol consumption\n14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.\n\n    Diabetes related:\n15. Diabetes mellitus other than type 2\n16. Diabetic ketoacidosis at Screening\n17. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening\n18. Patients on pioglitazone in the last 12 months prior to Screening.\n19. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months\n\n    Obesity related:\n20. BMI\\>45 kg\u002Fm2 at screening\n21. Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24.\n\nCardiovascular related:\n\n21\\. History of or current unstable cardiac dysrhythmias 22. Unstable heart failure 23. Uncontrolled hypertension 24. Stroke or transient ischemic attack\n\nGeneral safety:\n\n25\\. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and\u002For adequate follow up 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \\\u003C 60 mL\u002Fmin 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28. Patients on Vitamin E at doses ≥ 400 IU\u002Fday; doses of ≥ 400 IU\u002Fday are allowed when no qualitative change in dose for 6 months prior to Screening 29. Have a known hypersensitivity to any of the IMPs 30. Previous exposure to lanifibranor or empagliflozin 31. Present pregnancy\u002Flactation 32. Metallic implant of any sort that prevents MRI examination 33. Participation in any clinical trial of an approved or non approved investigational medicinal product\u002Fdevice within 3 months from Screening or five half-lives of the investigational drug from Screening.","ALL","18 Years",{"count":446,"type":447},42,"ACTUAL","INTERVENTIONAL",[450],"PHASE2","The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.",[453,454],"NASH - Nonalcoholic Steatohepatitis","Diabetes Mellitus, Type 2","COMPLETED","2024-07-08",{"date":458,"type":447},"2024-07-09",{"date":460,"type":447},"2022-06-29",{"date":462,"type":447},"2024-06-04",{"name":5,"class":6}]