The trial is taking place at:
Q

Quest Clinical Research | San Francisco, CA

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A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

I

Inventiva Pharma

Status and phase

Enrolling
Phase 3

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Drug: Placebo
Drug: IVA337

Study type

Interventional

Funder types

Industry

Identifiers

NCT04849728
337HNAS20011

Details and patient eligibility

About

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Full description

Primary objectives This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives: Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology. Part B To assess the safety of lanifibranor beyond the DBPC period. 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 on other key histological features of NASH (only for DBPC period) To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period) To assess the effect of lanifibranor on liver tests To assess the effect of lanifibranor on glycaemic parameters To assess the effect of lanifibranor on lipid parameters To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography. To assess the effect of lanifibranor on health-related quality of life To assess the safety of lanifibranor To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Prescreening Criteria:

  • Diagnosed with NASH on prior liver biopsy
  • Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on ultrasound
  • At least 3 of the components of metabolic syndrome

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

No qualitative change in 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): for at least 3 months
  • Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
  • Statins: for at least 3 months
  • No qualitative change in dose for all other chronically administered drugs 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
  • AST<0.6 ULN if the liver biopsy has to be performed in the scope of the study
  • 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

Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months before screening or historical biopsy.

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.

Cardiovascular related:

  • History of heart failure with reduced left ventricular ejection fraction (LVEF)
  • Atrial fibrillation requiring anticoagulation
  • Unstable heart failure

Uncontrolled hypertension at Screening (values >160/100 mm Hg)

General safety:

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,000 participants in 3 patient groups, including a placebo group

Lanifibranor (IVA 337) (800 mg/day)
Experimental group
Description:
2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)
Treatment:
Drug: IVA337
Drug: Placebo
Lanifibranor (IVA 337) (1200 mg/day)
Experimental group
Description:
3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)
Treatment:
Drug: IVA337
Matching placebo
Placebo Comparator group
Description:
3 Placebo to match tablets with food --> once a day (quaque die, QD)
Treatment:
Drug: Placebo

Trial contacts and locations

491

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Central trial contact

Pascaline Clerc

Data sourced from clinicaltrials.gov

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