A study of lanifibranor treatment in adults with nonalcoholic fatty liver disease

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    What is this study about?

    This study is a two-part trial looking at how well a drug called Lanifibranor works for adults suffering from liver diseases known as NASH and fibrosis stages F2 and F3. In the first part of the trial, the researchers will compare the effects of Lanifibranor with a placebo, which is a substance with no medical effect. The researchers will be looking at how much the drug can improve the health of the liver. The second part of the study will continue the use of Lanifibranor to see if there are any long-term safety issues. Apart from studying the drug’s effectiveness in resolving NASH and reducing live fibrosis, the trial will also be observing how it affects other aspects of liver health, diabetes, blood sugar and fat levels, liver stiffness and patients’ quality of life.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Innsbruck , Austria

      Edegem , Belgium

      Bruxelles , Belgium

      Leuven , Belgium

      Genk , Belgium

      Gent , Belgium

      Gent , Belgium

      Sint-Niklaas , Belgium

      Brugge , Belgium

      Roeselare , Belgium

      Brussel , Belgium

      Liu00e8ge , Belgium

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Veliko Tarnovo , Bulgaria

      Plzen , Czechia

      Praha , Czechia

      Strasbourg , France

      Marseille , France

      Dijon , France

      Besanu00e7on , France

      Lille , France

      Clichy , France

      Cru00e9teil , France

      Paris , France

      Paris , France

      Villejuif , France

      Rennes , France

      Grenoble , France

      Limoges , France

      Nantes , France

      Vandu0153uvre-lu00e8s-Nancy , France

      Vandu0153uvre-lu00e8s-Nancy , France

      Angers Cedex 9 , France

      Angers , France

      Nantes , France

      Pessac , France

      Pessac , France

      Montpellier , France

      Toulouse , France

      Toulouse , France

      Nice , France

      Clermont-Ferrand , France

      Lyon , France

      Paris , France

      Karlsruhe , Germany

      Wiesbaden , Germany

      Herne , Germany

      Mainz , Germany

      Homburg , Germany

      Chemnitz , Germany

      Dresden , Germany

      Leipzig , Germany

      Lu00fcbeck , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Ku00f6ln , Germany

      Northeim , Germany

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      San Giovanni Rotondo , Italy

      Milano , Italy

      Bologna , Italy

      Milan , Italy

      Napoli , Italy

      Novara , Italy

      Palermo , Italy

      Roma , Italy

      Roma , Italy

      Torino , Italy

      Nijmegen , Netherlands

      Amsterdam , Netherlands

      Tilburg , Netherlands

      Uden , Netherlands

      Rotterdam , Netherlands

      Rotterdam , Netherlands

      Utrecht , Netherlands

      Wrocu0142aw , Poland

      Wrocu0142aw , Poland

      Gdynia , Poland

      Mysu0142owice , Poland

      Katowice , Poland

      Katowice , Poland

      Poznau0144 , Poland

      u0141u00f3du017a , Poland

      Czestochowa , Poland

      Guimaru00e3es , Portugal

      Braga , Portugal

      Lisboa , Portugal

      Porto , Portugal

      Senhora Da Hora , Portugal

      Viana Do Castelo , Portugal

      Vila Real , Portugal

      Palma De Mallorca , Spain

      Sabadell , Spain

      Santander , Spain

      Santiago de Compostela , Spain

      Majadahonda , Spain

      Almeru00eda , Spain

      Badalona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Leu00f3n , Spain

      Madrid , Spain

      Madrid , Spain

      Mu00e1laga , Spain

      Pontevedra , Spain

      Sevilla , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      Valladolid , Spain

      Zaragoza , Spain

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Manchester , United Kingdom

      Newcastle Upon Tyne , United Kingdom

      Nottingham , United Kingdom

      Sheffield , United Kingdom

      Surrey Quays , United Kingdom

      Glasgow , United Kingdom

      London , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      I haven’t been able to locate the specific steps that patients need to take in this clinical trial in the data provided. Typically, such steps include eligibility screening, informed consent, baseline assessments, receiving the study treatment, regular monitoring, and follow-up assessments after the treatment period ends. If you provide more detailed questions or specific sections you are interested in, I can certainly assist you further.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to meet the following prescreening criteria related to diseases:

      1. Diagnosed with NASH (Nonalcoholic Steatohepatitis) on prior liver biopsy
      2. Type 2 diabetes with high waist circumference or obesity, or hepatic steatosis on ultrasound
      3. At least 3 of the components of metabolic syndrome

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The inclusion criteria to join the study, along with explanations for the medical terms, are as follows:

      Inclusion Criteria:

      1. Male or female, aged ≥18 years at the time of signing informed consent
      2. Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
        1. Steatosis score ≥1: Steatosis refers to the presence of fat in the liver.
        2. Activity score: A3 or A4: The activity score is part of the SAF scoring system for NASH, which assesses the degree of inflammation and ballooning in the liver, with A3 and A4 indicating severe activity.
        3. Fibrosis score: F2 or F3: Fibrosis refers to the thickening or scarring of tissue and scores F2 or F3 on the SAF scale indicate significant fibrosis, but not cirrhosis (which is F4).
      3. No qualitative change in dose for the drugs listed below:
        1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months. GLP1 receptor agonists and SGLT2 inhibitors are types of diabetes medications that affect insulin production and glucose removal via the kidneys, respectively.
        2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months.
        3. Statins: for at least 3 months. Statins are drugs that can lower cholesterol.
      4. No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening.
      5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods).
      6. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation.

      What Reasons Could Exclude Me from the Study?

      You cannot take part in the clinical trial if you meet any of the following conditions:

      Liver-related:

      1. Documented causes of chronic liver disease other than Non-Alcoholic Steatohepatitis (NASH).
      2. Diagnosed cirrhosis of the liver (stage F4 fibrosis).
      3. History or current diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer.
      4. History of or planned liver transplant.
      5. Positive test for Human Immunodeficiency Virus (HIV).
      6. Liver enzymes Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) greater than five times the upper limit of normal (ULN).
      7. If AST is less than 0.6 times the lower limit of normal (ULN) and a liver biopsy needs to be performed as part of the study.
      8. Abnormal liver synthetic function as determined by the clinical trial’s central laboratory evaluations.
      9. Low haemoglobin levels: less than 110 grams per liter (g/L) for females, and less than 120 g/L for males.
      10. Currently receiving any approved treatments for NASH or obesity.
      11. Current or recent history (within the past 5 years) of significant alcohol consumption.
      12. Treatment with drugs known to cause NAFLD for at least 2 weeks within the 12 months prior to the qualifying liver biopsy.

      Glycaemic control related:

      1. Hemoglobin A1c (HbA1c) levels greater than 9% during Screening.
      2. Any form of diabetes other than type 2.
      3. Currently undergoing treatment with insulin.
      4. Treatment with PPAR-gamma agonists (Thiazolidinediones [TZDs]) within 12 months prior to screening or historical biopsy.

      Obesity related:

      1. Bariatric surgery: Restrictive procedures allowed if performed more than 6 months before the qualifying liver biopsy; however, malabsorptive procedures or combinations of restrictive and malabsorptive methods are not allowed within 5 years of the biopsy.

      Cardiovascular related:

      1. History of heart failure with reduced Left Ventricular Ejection Fraction (LVEF), indicating less efficient pumping of blood by the heart.
      2. Atrial fibrillation requiring anticoagulation, a heart rhythm disorder needing blood-thinning medications.
      3. Unstable heart failure, meaning your heart is unable to pump blood effectively.
      4. Uncontrolled hypertension at Screening, with blood pressure values greater than 160/100 millimeters of mercury (mm Hg).

      General safety:

      1. Women who are currently breastfeeding.
      2. Previous exposure to the study drug, lanifibranor.
      3. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer.
      4. Concomitant treatment with PPAR-alpha agonists (Fibrates).

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The study involves the following drug:

      1. Lanifibranor (IVA337): This is the active substance used in the study. It is an experimental drug administered as tablets of 400 mg. In the study, patients will be randomized to receive lanifibranor at a dose of either 800 mg/day (2 Lanifibranor tablets + 1 placebo tablet) or 1200 mg/day (3 Lanifibranor tablets). The treatment is given with food once a day.

      A brief description of Lanifibranor:
      Lanifibranor is a new chemical entity that activates all three peroxisome proliferator-activated receptor (PPAR) isoforms with moderate selectivity for PPARα and PPARγ, which are known to play a central role in controlling metabolic pathways involved in liver diseases such as NASH, by improving insulin sensitivity, glucose homeostasis, and lipid metabolism, and by reducing inflammation.

      Since lanifibranor is the active substance involved, a placebo is also used as a comparator in the study. The placebo matches the lanifibranor tablets but does not contain the active substance.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being evaluated in this clinical trial is Lanifibranor. Here is a list of the active substances included, along with a description for each:

      1. Lanifibranor (IVA 337): Patients in the clinical trial will be randomised to receive either 800 mg/day or 1200 mg/day of Lanifibranor. Lanifibranor is known in the medical literature as a peroxisome proliferator-activated receptor (PPAR) agonist. It is being studied for its potential in treating non-alcoholic steatohepatitis (NASH) with liver fibrosis. It has been previously studied in earlier clinical trial phases and is now undergoing Phase 3 trials to further evaluate its efficacy and safety.

      Study ID

      CT-EU-00054242

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III

      Medicinal Product