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LEGEND: 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

Sponsor
Inventiva Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05232071
Collaborator
(none)
63
Enrollment
41
Locations
3
Arms
12.1
Anticipated Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 inhibitor on glycemic control.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lanifibranor (IVA337) (800 mg/day)

2 Lanifibranor tablets 400 mg with food --> once a day (quaque die, QD)

Drug: IVA337
800 mg
Other Names:
  • Lanifibranor

    		•
    Placebo Comparator: Matching placebo

    2 Placebo to match tablets with food --> once a day (quaque die, QD)

    Drug: Placebo
    Placebo to match
    Experimental: 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)

    Drug: IVA337
    800 mg
    Other Names:
  • Lanifibranor

    • Drug: Empagliflozin
    10 mg
    Other Names:
  • Jardiance

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of the effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24 [Date of randomisation until the end of treatment at week 24]

      Absolute change in HbA1c from baseline (Week 0) to Week 24

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, aged ≥ 18 years at the time of signing informed consent

    2. Diagnosis of NASH, based on histology or ct1>875msecs by LiverMuliScan 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:
    Liver-related:

    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 ≥ 1.3 mg/dL (22.2 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is within normal reference range)

    1. Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males

    2. WBC < LLN

    3. Platelet count < 150,000/µL

    4. ALP > 2 × ULN

    5. Patient currently receiving any approved treatment for NASH or obesity

    6. Current or recent history (< 5 years) of significant alcohol consumption

    7. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.

    Diabetes related:

    1. Diabetes mellitus other than type 2

    2. Diabetic ketoacidosis at Screening

    3. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening

    4. 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:

    1. BMI>45 kg/m2 at screening

    2. 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:

    1. History of or current unstable cardiac dysrhythmias

    2. Unstable heart failure

    3. Uncontrolled hypertension

    4. Stroke or transient ischemic attack

    General safety:

    1. 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

    2. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min

    3. Concomitant treatment with PPAR-⍺ agonists (fibrates)

    4. Have a known hypersensitivity to any of the IMPs

    5. Previous exposure to lanifibranor or empagliflozin

    6. Present pregnancy/lactation

    7. Metallic implant of any sort that prevents MRI examination

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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 Institute for Liver Health dba Arizona Liver Health Chandler Arizona United States 85224
    4 ARcare Center for Clinical Research Conway Arkansas United States 72032
    5 Velocity Clinical Research Gardena California United States 90247
    6 National Research Institute Huntington Park California United States 90255
    7 Cadena Care Institute, LLC Poway California United States 92064
    8 Florida Research Institute Lakewood Ranch Florida United States 34211
    9 Prolive Medical Research Miami Florida United States 33175
    10 Indiana University School of Medicine Indianapolis Indiana United States 46202
    11 Digestive Health Research of Southern California South Bend Indiana United States 46635
    12 Tandem Clinical Research - New Orleans Area Site Marrero Louisiana United States 70072
    13 Harvard Medical School Boston Massachusetts United States 02115
    14 Mayo Clinic Rochester Minnesota United States 55905
    15 AIG Digestive Disease Research Florham Park New Jersey United States 07932
    16 Digestive Disease Research Center, LLC Greenwood South Carolina United States 29646
    17 Digestive Health Research Hermitage Tennessee United States 37076
    18 Accelemed Research Institute Austin Texas United States 78745
    19 Dallas Diabetes Research Center Dallas Texas United States 75230
    20 American Research Corporation San Antonio Texas United States 78215
    21 Diabetes & Glandular Disease Clinic, P.A. San Antonio Texas United States 78229
    22 Impact Research Institute Waco Texas United States 76710
    23 Digestive Health Research of North Texas Wichita Falls Texas United States 76301
    24 University of Virginia Charlottesville Virginia United States 22908
    25 Central Virginia VA Healthcare System Richmond Virginia United States 23249
    26 CUB Erasme Hospital Brussels Belgium 1070
    27 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
    28 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    29 AZ Maria Middelares Gent Belgium 9000
    30 UZ GENT Gent Belgium 9000
    31 CHU Angers_Service d'hepatogastro-enterologie Angers France 49000
    32 CHU Limoges Limoges France 87042
    33 Hopital Saint Antoine Paris France 75012
    34 CHU Bordeaux Pessac France 33604
    35 Chu Rangueil Toulouse France 31059
    36 HGE CHRU Nancy Vandoeuvre-lès-Nancy France 54500
    37 Amsterdam UMC Amsterdam Netherlands 1105 AZ
    38 Hull University Teaching Hospital Hull United Kingdom HU32JZ
    39 King's College Hospital London United Kingdom SE59RS
    40 St Georges Hospital London United Kingdom SW17 0QT
    41 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 7RU

    Sponsors and Collaborators

    • Inventiva Pharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inventiva Pharma
    ClinicalTrials.gov Identifier:
    NCT05232071
    Other Study ID Numbers:
    • 337HNAS21016
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Empagliflozin

    Study Results

    No Results Posted as of Aug 25, 2022