Scientific and clinical resources for healthcare professionals

Inventiva Medical Affairs

Inventiva Medical Affairs supports scientific exchange and provides resources for healthcare professionals, researchers, and qualified stakeholders interested in MASH and lanifibranor.

About MASH

Metabolic dysfunction-associated steatohepatitis is a progressive liver disease associated with metabolic risk factors and significant long-term complications.

MASH can lead to fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma. It is also closely associated with cardiometabolic disease, including obesity, type 2 diabetes, and dyslipidemia.

Medical Affairs resources are intended to support balanced scientific exchange and help qualified audiences understand the evolving clinical landscape.

About Lanifibranor

Lanifibranor is an investigational pan-PPAR agonist being evaluated for the treatment of MASH.

Lanifibranor is designed to activate all three PPAR isoforms: alpha, delta, and gamma. This multimodal approach is intended to target pathways involved in inflammation, fibrosis, and metabolic dysfunction.

The safety and efficacy of lanifibranor have not been established by regulatory authorities. It remains an investigational therapy.

Lanifibranor is currently being studied in a Phase 3 clinical development program.

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How Lanifibranor Works

Clinical Trials

Inventiva is evaluating lanifibranor across clinical studies designed to understand its potential in MASH and related metabolic populations.

NATiV3 Clinical Trial

A pivotal Phase 3 study evaluating lanifibranor in MASH

NATiV3 is designed to assess the efficacy and safety of lanifibranor in adults with MASH and fibrosis.

NATiV3 clinical trial overview

Trial Design

NATiV3 trial design diagram

Clinical Trial Sites

Clinical trial sites map ClinicalTrials.gov

Previous Clinical Trials

NATIVE (Phase 2b)
24 weeks

Patient Population/Inclusion Criteria

Biopsy-proven MASH; SAF scores: Steatosis (1-3), Activity (3-4), Fibrosis (4).

Dose Cohorts & Patients (N)

800mg (N=83), 1200mg (N=83), Placebo (N=81); Total N=247.

Efficacy Results

1200mg: 45% MASH resolution (p<0.001) and 42% fibrosis improvement (p=0.013).

AEs/Safety

Mean weight gain: 2.7kg at 1200mg. Most events were mild or moderate.

LEGEND (Phase 2)
24 weeks

Patient Population/Inclusion Criteria

Dose Cohorts & Patients (N)

Efficacy Results

AEs/Safety

Cusi Study (PI-led)

Patient Population/Inclusion Criteria

Dose Cohorts & Patients (N)

Efficacy Results

AEs/Safety

Publications

PARIS MASH 2026: Metabolic Benefits of Pan-PPAR Agonist Lanifibranor in Patients With and Without Type 2 Diabetes

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PARIS MASH 2026: Beyond the Liver: Cardiovascular Effects of the Pan-PPAR Agonist Lanifibranor in Patients with Mash

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PARIS MASH 2026: Lanifibranor Improves Metabolic and Histologic Features of MASH Across Multiple Preclinical Models: Convergent Pan-PPAR Activity

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PARIS MASH 2026: Partial PPARγ Agonism Underlies Lanifibranor’s Preclinical Fluid/ Cardiovascular Safety Versus Full and Dual PPAR Agonists

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PARIS MASH 2026: Lanifibranor Phase 1/2a Experience - PPARγ Engagement and Metabolic Activity Without Early Clinical Fluid Retention

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EASL2026: Lanifibranor-Induced Histological and Cardiometabolic Improvements in MASH Are Independent of Weight Change and Associated With Adiponectin Induction

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EASL 2026: Ultrastructural Assessment of Liver Sinusoidal Endothelial Cell Capillarisation in Metabolic Dysfunction-Associated Steatotic Liver Disease and Its Modulation by Lanifibranor

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MASH-TAG 2026: Comparative Modulation of Adiponectin Across Select Therapeutics in Clinical Development for MASH with Fibrosis Identifies Lanifibranor as a Differentiated Metabolic Modulator

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