A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2028
  • participants needed
    2000
  • sponsor
    Inventiva Pharma
Updated on 22 September 2022
Investigator
Michael Cooreman, MD
Primary Contact
Advanced Research Institute (4.5 mi away) Contact
+183 other location

Summary

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3

Description

Primary objectives

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2, with the following primary

objectives

Part 1 To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology.

Part 2 To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.

Secondary objectives

Key secondary objectives of Part 1:

  • To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis
  • To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH

Other secondary objectives of both Part 1 and Part 2:

  • To assess the effect of lanifibranor compared to placebo on other key histological features of NASH
  • To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis in diabetic patients
  • To assess the effect of lanifibranor compared to placebo on liver function tests
  • To assess the effect of lanifibranor compared to placebo on glycaemic parameters
  • To assess the effect of lanifibranor compared to placebo on lipid parameters
  • To assess the effect of lanifibranor compared to placebo on liver stiffness
  • To assess the effect of lanifibranor compared to placebo on health-related quality of life
  • To assess the long-term safety (up to 7 years) of lanifibranor
  • To assess population PK modeling of lanifibranor using sparse sampling scheme

Details
Condition NASH - Nonalcoholic Steatohepatitis
Treatment Placebo, IVA337, Lanifibranor
Clinical Study IdentifierNCT04849728
SponsorInventiva Pharma
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged ≥18 years at the time of signing informed consent
Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF)
Steatosis score ≥1
Activity score: A3 or A4
Fibrosis score: F2 or F3
Stable dose for the drugs listed below
Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): Stable dose for at least 3 months
Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months
Statins: Stable dose for at least 3 months
All other chronically administered drugs must be stable for at least 3 months prior to
Screening
Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
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

Exclusion Criteria

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
Positive human immunodeficiency virus (HIV) serology
ALT or AST >5 × ULN
Abnormal synthetic liver function as defined by Screening central laboratory evaluation
Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males
Patient currently receiving any approved treatment for NASH or obesity
Current or recent history (<5 years) of significant alcohol consumption
Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy
Glycaemia related
HbA1c >9% at Screening
Diabetes mellitus other than type 2
Current treatment with insulin
Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])
Obesity related
Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to the qualifying liver biopsy; malabsorptive procedures and procedures combining both restrictive and malabsorptive methods are not allowed within 5 years of the qualifying liver biopsy
History of heart failure with reduced left ventricular ejection fraction (LVEF)
Atrial fibrillation requiring anticoagulation
Unstable heart failure
Cardiovascular related
Uncontrolled hypertension at Screening (values >160/100 mm Hg)
Women currently breastfeeding
Previous exposure to lanifibranor
Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer
Concomitant treatment with PPAR-alpha agonists (fibrates)
General safety
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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