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
NCT ID: NCT05232071
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2022-06-29
2024-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lanifibranor (IVA337) (800 mg/day)
2 Lanifibranor tablets 400 mg with food --\> once a day (quaque die, QD)
IVA337
800 mg
Matching placebo
2 Placebo to match tablets with food --\> once a day (quaque die, QD)
Placebo
Placebo to match
Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --\> once a day (quaque die, QD)
IVA337
800 mg
Empagliflozin
10 mg
Interventions
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IVA337
800 mg
Placebo
Placebo to match
Empagliflozin
10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.
Exclusion Criteria
1. Documented causes of chronic liver disease other than NASH
2. Histologically documented liver cirrhosis (fibrosis stage F4)
3. History or current diagnosis of hepatocellular carcinoma (HCC)
4. History of or planned liver transplant
5. Documented history of human immunodeficiency virus (HIV) infection
6. ALT or AST \> 5 × upper limit of normal (ULN)
7. 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) )
8. Hemoglobin \< 110 g/L (11 g/dL) for females and \< 120 g/L (12 g/dL) for males
9. WBC \< LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
10. Platelet count \< 140,000/µL
11. ALP \> 2 × ULN
12. Patient currently receiving any approved treatment for NASH or obesity
13. Current or recent history (\< 5 years) of significant alcohol consumption
14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.
Diabetes related:
15. Diabetes mellitus other than type 2
16. Diabetic ketoacidosis at Screening
17. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening
18. Patients on pioglitazone in the last 12 months prior to Screening.
19. 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:
20. BMI\>45 kg/m2 at screening
21. 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.
18 Years
ALL
No
Sponsors
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Inventiva Pharma
INDUSTRY
Responsible Party
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Locations
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Birmingham Digestive Health Research
Homewood, Alabama, United States
Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, United States
ARcare Center for Clinical Research
Conway, Arkansas, United States
ARcare Center for Clinical Research
Little Rock, Arkansas, United States
Cure Clinical Research, LLC
Fountain Valley, California, United States
Velocity Clinical Research
Gardena, California, United States
National Research Institute
Huntington Park, California, United States
Cadena Care Institute, LLC
Poway, California, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Galenus Group
Lehigh Acres, Florida, United States
Prolive Medical Research
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Digestive Health Research of Southern California
South Bend, Indiana, United States
Tandem Clinical Research - New Orleans Area Site
Marrero, Louisiana, United States
Harvard Medical School
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
AIG Digestive Disease Research
Florham Park, New Jersey, United States
Digestive Health Research
Hermitage, Tennessee, United States
Accelemed Research Institute
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Impact Research Institute
Waco, Texas, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Central Virginia VA Healthcare System
Richmond, Virginia, United States
CUB Erasme Hospital
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
UZ GENT
Ghent, , Belgium
CHU Angers_Service d'hepatogastro-enterologie
Angers, , France
CHU Limoges
Limoges, , France
Hopital Saint Antoine
Paris, , France
CHU Bordeaux
Pessac, , France
Chu Rangueil
Toulouse, , France
HGE CHRU Nancy
Vandœuvre-lès-Nancy, , France
Amsterdam UMC
Amsterdam, , Netherlands
Hull University Teaching Hospital
Hull, , United Kingdom
King's College Hospital
London, , United Kingdom
St Georges Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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337HNAS21016
Identifier Type: -
Identifier Source: org_study_id
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