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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 )

PHASE3RECRUITING

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

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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.

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

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-08-19

Primary completion: 2025-09-30

Study completion finish: 2026-09-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04849728

Intervention or treatment

DRUG: IVA337

DRUG: Placebo

Conditions

• NASH - Nonalcoholic Steatohepatitis

Image related to NASH - Nonalcoholic Steatohepatitis

Condition: NASH - Nonalcoholic Steatohepatitis
DRUG: IVA337 and other drugs
Concord, New South Wales, Australia and more
Sponsor: Inventiva Pharma

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Concord Repatriation General Hospital

Research sites nearby

Select from list below to view details:

Concord Repatriation General Hospital
Concord, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Lanifibranor (IVA 337) (800 mg/day) 2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD)	DRUG: IVA337 A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.
EXPERIMENTAL: Lanifibranor (IVA 337) (1200 mg/day) 3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD)	DRUG: IVA337 A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.
PLACEBO_COMPARATOR: Matching placebo 3 Placebo to match tablets with food --\> once a day (quaque die, QD)	DRUG: Placebo A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Resolution of NASH and improvement of fibrosis	Part A: DBPC: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline	Part A: Date of randomisation until the date of biopsy at Week 72
Safety Analyses	Part B: ATE: * Using the DBPC on-treatment period, comparing the 2 active arms versus placebo * Using the DBPC +ATE on treatment periods, assessing the 2 active arms. For adverse events, adjudicated liver events, and DILI and MACE events, in addition to the raw cumulative incidence proportions, the exposure-adjusted incidence rates will be provided based on the time patients are at risk.	48 weeks after completion of DBPC period

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: 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 )