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ACTIVE NOT RECRUITING

NCT04849728

PHASE3

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 )

Sponsor: Inventiva Pharma

View on ClinicalTrials.gov

Summary

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

Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis Stages F2 and F3

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2021-08-19

Completion Date

2027-09-30

Last Updated

2026-11-02

Healthy Volunteers

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

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.

DRUG

Placebo

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: 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 2. Activity score: A3 or A4 3. Fibrosis score: F2 or F3 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 2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months 3. Statins: for at least 3 months 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. Exclusion Criteria: Liver-related: 1. Documented causes of chronic liver disease other than NASH 2. Histologically documented liver cirrhosis (fibrosis stage F4) 3. History or current diagnosis of hepatocellular carcinoma (HCC) 4. History of or planned liver transplant 5. Positive human immunodeficiency virus (HIV) serology 6. ALT or AST \>5 × ULN 7. AST\<0.6 ULN if the liver biopsy has to be performed in the scope of the study 8. Abnormal synthetic liver function as defined by Screening central laboratory evaluation 9. Haemoglobin \<110 g/L (11 g/dL) for females and \<120 g/L (12 g/dL) for males 10. Patient currently receiving any approved treatment for NASH or obesity 11. Current or recent history (\<5 years) of significant alcohol consumption 12. 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: 13. HbA1c \>9% at Screening 14. Diabetes mellitus other than type 2 15. Current treatment with insulin 16. Treatment with PPAR-gamma agonists (thiazolidinediones \[TZDs\]) 12 months before screening or historical biopsy. Obesity related: 17. 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: 18. History of heart failure with reduced left ventricular ejection fraction (LVEF) 19. Atrial fibrillation requiring anticoagulation 20. Unstable heart failure 21. Uncontrolled hypertension at Screening (values \>160/100 mm Hg) General safety: 22. Women currently breastfeeding 23. Previous exposure to lanifibranor 24. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer 25. Concomitant treatment with PPAR-alpha agonists (fibrates)

Locations (459)

Objective Health - Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Digestive Health Specialist of the Southeast

Dothan, Alabama, United States

North Alabama GI Research Center llc

Madison, Alabama, United States

The Institute For Liver Health - Chandler

Chandler, Arizona, United States

Arizona Liver Health - Peoria

Peoria, Arizona, United States

Dignity Health - St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Adobe Gastroenterology

Tucson, Arizona, United States

Arizona Liver Health

Tucson, Arizona, United States

ARcare Center for Clinical Research - Conway

Conway, Arkansas, United States

ARcare Center for Clinical Research

Little Rock, Arkansas, United States

Arkansas Diagnostic Center

Little Rock, Arkansas, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Summit - Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Fomatmedicalresearch

Camarillo, California, United States

GW Research

Chula Vista, California, United States

Velocity Clinical Research, Chula Vista

Chula Vista, California, United States

TriWest Research Associates

El Cajon, California, United States

Cure Clinical Research, LLC

Fountain Valley, California, United States

SC Clinical Research

Garden Grove, California, United States

Velocity Clinical Research - Gardena

Gardena, California, United States

National Research Institute - Santa Ana

Huntington Park, California, United States

The Clinical Trials Network - Gastro Care Institute

Lancaster, California, United States

National Research Institute - Westlake

Los Angeles, California, United States

National Research Institute - Panorama City

Panorama City, California, United States

California Liver Reearch

Pasadena, California, United States

Cadena Care Institute

Poway, California, United States

Stanford University Medical Center

Redwood City, California, United States

Research and Education, Inc.

San Diego, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

Quest Clinical Research

San Francisco, California, United States

Silicon Valley Research Institute

San Jose, California, United States

Clinical Trial Management Services

Thousand Oaks, California, United States

San Fernando Valley Health Institute

Van Nuys, California, United States

South Denver Gastroenterology - Swedish Medical Center Office

Englewood, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Synergy Healthcare

Bradenton, Florida, United States

Florida Research Institute

Bradenton, Florida, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Gastro Florida

Clearwater, Florida, United States

Hi Tech and Global Research, LLC

Coral Gables, Florida, United States

JY Research Institute Inc.

Cutler Bay, Florida, United States

Top Medical Research

Cutler Bay, Florida, United States

Doral Medical Research, LLC

Hialeah, Florida, United States

Palmetto Research

Hialeah, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

Galenus Group

Lehigh Acres, Florida, United States

Accel Research Sites

Maitland, Florida, United States

Centor for Advanced Gastroenterology - Main Office - Maitland

Maitland, Florida, United States

Florida Vascular Research

Miami, Florida, United States

Life Medical Research Group

Miami, Florida, United States

Schiff Center for Liver Diseases

Miami, Florida, United States

D&H National Research Centers

Miami, Florida, United States

Future Care Solution

Miami, Florida, United States

Genoma Research Group

Miami, Florida, United States

Gastro Health - Galloway

Miami, Florida, United States

Pro Live Medical Research

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Clinical Trials Services Corporation

Miami, Florida, United States

Advanced Research Institute

New Port Richey, Florida, United States

Sensible Healthcare Clinical Research

Ocoee, Florida, United States

AdventHealth Transplant Institute

Orlando, Florida, United States

Digestive and Liver Center of Florida - Orlando

Orlando, Florida, United States

IMIC Research - International Medical Investigations Centers

Palmetto Bay, Florida, United States

American Research Centers of Florida

Pembroke Pines, Florida, United States

Pensacola GI Research Center

Pensacola, Florida, United States

Eminat, LLC

Plantation, Florida, United States

D & H Pompano Research Center

Pompano Beach, Florida, United States

NAPA Research

Pompano Beach, Florida, United States

Covenant Metabolic Specialists LLC - Sarasota

Sarasota, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Florida Medical Clinic - Zephyrhills

Zephyrhills, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Oracle Clinical Research

College Park, Georgia, United States

IACT Health

Columbus, Georgia, United States

Southeast Clinical Research Center

Dalton, Georgia, United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

ASHA Clinical Research - Munster

Hammond, Indiana, United States

Heartland Medical Research

Clive, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Arizona Digestive Health - Sun City

Kansas City, Kansas, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Kansas Medical Clinic - Gastroenterology

Topeka, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Tandem Clinical Research GI

Houma, Louisiana, United States

Combined Gastro Research LLC

Lafayette, Louisiana, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Metropolitan Gastroenterology Associates - Metairie

Metairie, Louisiana, United States

Louisiana Research Center LLC

Shreveport, Louisiana, United States

Mercy Medical Center - Mcauley Plaza

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Digestive Disease Associates - Catonsville

Catonsville, Maryland, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Mid-Atlantic GI Research

Greenbelt, Maryland, United States

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

And 359 more locations on ClinicalTrials.gov

Clinical Research Directory

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 )

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (459)