Status:
COMPLETED
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
Lead Sponsor:
Inventiva Pharma
Conditions:
NASH - Nonalcoholic Steatohepatitis
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 inhibit...
Eligibility Criteria
Inclusion
- Male or female, aged ≥ 18 years at the time of signing informed consent
- 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
- HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months
- Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.
Exclusion
- Liver-related:
- Documented causes of chronic liver disease other than NASH
- Histologically documented liver cirrhosis (fibrosis stage F4)
- History or current diagnosis of hepatocellular carcinoma (HCC)
- History of or planned liver transplant
- Documented history of human immunodeficiency virus (HIV) infection
- ALT or AST \> 5 × upper limit of normal (ULN)
- Abnormal liver function as defined by central laboratory evaluation:
- Albumin \< LLN INR ≥ 1.3 (unless patient is on anticoagulants) Total bilirubin level ≥ 1.5 mg/dL (25.7 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L) )
- Hemoglobin \< 110 g/L (11 g/dL) for females and \< 120 g/L (12 g/dL) for males
- WBC \< LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
- Platelet count \< 140,000/µL
- ALP \> 2 × ULN
- Patient currently receiving any approved treatment for NASH or obesity
- Current or recent history (\< 5 years) of significant alcohol consumption
- Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.
- Diabetes related:
- Diabetes mellitus other than type 2
- Diabetic ketoacidosis at Screening
- Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening
- Patients on pioglitazone in the last 12 months prior to Screening.
- 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
- Obesity related:
- BMI\>45 kg/m2 at screening
- 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.
- Cardiovascular related:
- 21\. History of or current unstable cardiac dysrhythmias 22. Unstable heart failure 23. Uncontrolled hypertension 24. Stroke or transient ischemic attack
- General safety:
- 25\. 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/or adequate follow up 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \< 60 mL/min 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28. Patients on Vitamin E at doses ≥ 400 IU/day; doses of ≥ 400 IU/day 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/lactation 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/device within 3 months from Screening or five half-lives of the investigational drug from Screening.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05232071
Start Date
June 29 2022
End Date
June 4 2024
Last Update
July 9 2024
Active Locations (42)
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1
Birmingham Digestive Health Research
Homewood, Alabama, United States, 35209
2
Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, United States, 85224
3
ARcare Center for Clinical Research
Conway, Arkansas, United States, 72032
4
ARcare Center for Clinical Research
Little Rock, Arkansas, United States, 72205