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 )
Launched by INVENTIVA PHARMA · Apr 16, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called NATiV3, is studying a new treatment called lanifibranor for adults with a liver condition known as Nonalcoholic Steatohepatitis (NASH) and fibrosis stages F2 or F3. NASH is a serious liver disease that can lead to scarring of the liver and other health problems. The trial aims to see if lanifibranor can effectively improve liver health and safety in patients. The study is currently recruiting participants aged 18 and older who have been diagnosed with NASH and meet certain health criteria, such as having type 2 diabetes or specific signs of metabolic syndrome.
Participants in the trial will undergo a screening process to ensure they meet the eligibility criteria, which includes having a recent liver biopsy confirming their condition. If eligible, they can expect to receive either the study drug or a placebo (a non-active treatment) and will be closely monitored throughout the study. It’s important for potential participants to be aware that they should not have certain liver conditions or be on specific medications that could interfere with the trial. Overall, this study represents a hopeful step towards finding effective treatments for NASH.
Gender
ALL
Eligibility 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:
- • 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)
About Inventiva Pharma
Inventiva Pharma is a biopharmaceutical company dedicated to the development of innovative therapies for the treatment of fibrotic diseases, metabolic disorders, and other unmet medical needs. With a strong focus on small molecule drug discovery and development, Inventiva leverages its expertise in molecular biology and pharmacology to advance its pipeline of oral therapeutics. The company is committed to addressing significant health challenges through rigorous clinical trials and collaborations, aiming to provide effective solutions that enhance patient outcomes and improve quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Durham, North Carolina, United States
Charleston, South Carolina, United States
San Francisco, California, United States
Iowa City, Iowa, United States
Bridgeport, Connecticut, United States
Boston, Massachusetts, United States
Rochester, New York, United States
Fort Sam Houston, Texas, United States
Liverpool, New South Wales, Australia
Zaragoza, , Spain
Penrith, New South Wales, Australia
Perth, Western Australia, Australia
Zaragoza, , Spain
Concord, New South Wales, Australia
Detroit, Michigan, United States
Staten Island, New York, United States
Houston, Texas, United States
Nashville, Tennessee, United States
Toronto, Ontario, Canada
Salt Lake City, Utah, United States
Herston, Queensland, Australia
Anniston, Alabama, United States
Badalona, , Spain
Tampa, Florida, United States
Weston, Florida, United States
New York, New York, United States
Barcelona, , Spain
Oklahoma City, Oklahoma, United States
Chevy Chase, Maryland, United States
Pilar, Buenos Aires, Argentina
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Burlington, Vermont, United States
Pittsburgh, Pennsylvania, United States
Charlottesville, Virginia, United States
New Lambton, New South Wales, Australia
Clayton, Victoria, Australia
North Little Rock, Arkansas, United States
Phoenix, Arizona, United States
Rochester, Minnesota, United States
Clearwater, Florida, United States
Heidelberg, Victoria, Australia
Barcelona, , Spain
Santander, Cantabria, Spain
Alcorcón, Madrid, Spain
Madrid, , Spain
Santander, , Spain
Valencia, , Spain
Cleveland, Ohio, United States
Fayetteville, North Carolina, United States
Richmond, Virginia, United States
Atlanta, Georgia, United States
New York, New York, United States
Barcelona, , Spain
Norfolk, Virginia, United States
Paris, , France
Santiago De Compostela, , Spain
Lyon, , France
Beijing, Beijing, China
Summerville, South Carolina, United States
San Antonio, Texas, United States
Tel Aviv, , Israel
Porto Alegre, Rio Grande Do Sul, Brazil
Barcelona, , Spain
New Haven, Connecticut, United States
Málaga, , Spain
Tulsa, Oklahoma, United States
Edegem, Antwerpen, Belgium
Guangzhou, , China
Dallas, Texas, United States
Almería, , Spain
Chula Vista, California, United States
Burlington, Vermont, United States
Changchun, Jilin, China
Berlin, , Germany
Hagerstown, Maryland, United States
Monterrey, , Mexico
Utrecht, , Netherlands
Skokie, Illinois, United States
Buenos Aires, , Argentina
Nanning, Guangxi, China
Fairfax, Virginia, United States
Hamilton, Ontario, Canada
Zhengzhou, Henan, China
Columbus, Ohio, United States
Nanchang, Jiangxi, China
Xi'an, Shaanxi, China
Sevilla, , Spain
Murdoch, Western Australia, Australia
Houston, Texas, United States
Xi'an, Shanxi, China
Wenzhou, Zhejiang, China
Miami, Florida, United States
Chengdu, Sichuan, China
Mainz, Rheinland Pfalz, Germany
Barcelona, , Spain
Beijing, , China
Redwood City, California, United States
Fuzhou, Fujian, China
Valladolid, , Spain
Tianjin, , China
Fuzhou, , China
Beijing, Beijing, China
Chongqing, , China
San Giovanni Rotondo, Foggia, Italy
Gent, Oost Vlaanderen, Belgium
Valladolid, , Spain
Chongqing, , China
Chicago, Illinois, United States
Wyoming, Michigan, United States
Greenville, North Carolina, United States
Hialeah, Florida, United States
Nanjing, Jiangsu, China
Shanghai, , China
Milan, , Italy
Guangzhou, Guangdong, China
Napoli, , Italy
Suzhou, Jiangsu, China
Chesterfield, Michigan, United States
Arlington, Texas, United States
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Miami, Florida, United States
London, England, United Kingdom
New Port Richey, Florida, United States
Nottingham, England, United Kingdom
Qingdao, , China
Shenyang, , China
Haifa, , Israel
Garden Grove, California, United States
Dalian, , China
Greenslopes, Queensland, Australia
Brussel, , Belgium
Columbus, Georgia, United States
Köln, , Germany
Wenzhou, Zhejiang, China
Ningbo, , China
Braga, , Portugal
Guiyang, Guizhou, China
Saint Louis, Missouri, United States
Beijing, Beijing, China
Nanchang, Jiangxi, China
Oaxaca, , Mexico
Vaughan, Ontario, Canada
Miami, Florida, United States
Rialto, California, United States
Kansas City, Missouri, United States
El Cajon, California, United States
Milwaukee, Wisconsin, United States
San Jose, California, United States
Montréal, Quebec, Canada
Majadahonda, Madrid, Spain
Nantong, Jiangsu, China
Zhengzhou, , China
Rotterdam, , Netherlands
London, , United Kingdom
Zhengzhou, Henan, China
São José Do Rio Preto, São Paulo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Changchun, Jilin, China
Homburg, Saarland, Germany
Kansas City, Kansas, United States
León, , Spain
Shenzhen, , China
Rosario, Santa Fe, Argentina
Dothan, Alabama, United States
Lanzhou, Gansu, China
Beijing, Beijing, China
São José Do Rio Preto, , Brazil
Idaho Falls, Idaho, United States
Chesterfield, Missouri, United States
Changchun, , China
La Plata, Buenos Aires, Argentina
Torino, , Italy
Berlin, , Germany
Rapid City, South Dakota, United States
Dallas, Texas, United States
Seattle, Washington, United States
Shreveport, Louisiana, United States
Leesburg, Virginia, United States
Wuxi, Jiangsu, China
Santiago De Compostela, La Coruña, Spain
Viña Del Mar, Valparaíso, Chile
Chengdu, , China
Albuquerque, New Mexico, United States
Dresden, Sachsen, Germany
Lakewood Ranch, Florida, United States
Houston, Texas, United States
Clearwater, Florida, United States
Palermo, , Italy
Qingdao, Shandong, China
Guiyang, Guizhou, China
Zhengzhou, , China
Guiyang, , China
Ramat Gan, , Israel
Kunming, Yunnan, China
Little Rock, Arkansas, United States
Coral Gables, Florida, United States
Miami, Florida, United States
Marrero, Louisiana, United States
Gdańsk, , Poland
Valencia, , Spain
Grenoble, , France
San Antonio, Texas, United States
Fall River, Massachusetts, United States
Clermont Ferrand, , France
Nanchang, , China
Madrid, , Spain
Madrid, , Spain
Leuven, Flemish Brabant, Belgium
Ramat Gan, Tel Aviv, Israel
Newport News, Virginia, United States
Sofia, , Bulgaria
Clive, Iowa, United States
Sherman, Texas, United States
Zhengzhou, Henan, China
Luoyang, Henan, China
Miami, Florida, United States
Cutler Bay, Florida, United States
Cutler Bay, Florida, United States
Webster, Texas, United States
Nanjing, Jiangsu, China
Miami, Florida, United States
Englewood, Colorado, United States
Innsbruck, Tyrol, Austria
Nijmegen, Gelderland, Netherlands
Beaumont, Texas, United States
Huntington Park, California, United States
Brugge, West Vlaanderen, Belgium
Roma, , Italy
Wuhan, Hubei, China
Toulouse, Occitanie, France
Besançon, , France
London, England, United Kingdom
Karlsruhe, , Germany
Shenyang, Liaoning, China
Marseille, , France
Boca Raton, Florida, United States
Herne, Nordrhein Westfalen, Germany
Georgetown, Texas, United States
Porto, , Portugal
Van Nuys, California, United States
Karlsruhe, Baden Württemberg, Germany
Miami, Florida, United States
Pembroke Pines, Florida, United States
Austin, Texas, United States
Rennes, Ille Et Vilaine, France
Rancho Cucamonga, California, United States
Tucson, Arizona, United States
Panorama City, California, United States
Topeka, Kansas, United States
Columbus, Ohio, United States
Gent, Oost Vlaaderen, Belgium
Rotterdam, Zuid Holland, Netherlands
San Antonio, Texas, United States
Catonsville, Maryland, United States
Greenbelt, Maryland, United States
Wichita Falls, Texas, United States
Richmond, Virginia, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Genk, Limburg, Belgium
Toulouse, Occitanie, France
Falls Church, Virginia, United States
Paris, Ile De France, France
Nice, Provence Alpes Côte D'azur, France
Novara, , Italy
Flowood, Mississippi, United States
Germantown, Tennessee, United States
Paris, Ile De France, France
Tucson, Arizona, United States
Budapest, , Hungary
Sint Niklaas, Oost Vlaanderen, Belgium
Chemnitz, Sachsen, Germany
Waco, Texas, United States
Brampton, Ontario, Canada
Jerusalem, Jerusalem District, Israel
Veliko Tarnovo, , Bulgaria
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Manchester, England, United Kingdom
Preston, England, United Kingdom
Pompano Beach, Florida, United States
Roeselare, West Vlaanderen, Belgium
Vandœuvre Lès Nancy, Lorraine, France
Sabadell, Barcelona, Spain
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Cedar Park, Texas, United States
Dalton, Georgia, United States
Plzen, , Czechia
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São José Do Rio Preto, São Paulo, Brazil
Strasbourg, Bas Rhin, France
Maitland, Florida, United States
Guangzhou, Guangdong, China
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Stara Zagora, , Bulgaria
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Peoria, Arizona, United States
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Chula Vista, California, United States
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Maitland, Florida, United States
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Miami, Florida, United States
Miami, Florida, United States
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Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
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Buffalo, New York, United States
Charlotte, North Carolina, United States
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Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Liverpool, New South Wales, Australia
Bruxelles, Bruxelles Capitale, Belgium
Porto Alegre, Rio De Janeiro, Brazil
Cerqueira César, Sao Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Sofia, Sofia City, Bulgaria
Sofia, Sofia City, Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Calgary, Alberta, Canada
Praha, , Czechia
Marseille, Bouches Du Rhône, France
Besançon, Franche Comté, France
Lille, Hauts De France, France
Clichy, Ile De France, France
Créteil, Ile De France, France
Villejuif, Ile De France, France
Grenoble, Isère, France
Limoges, Limousin, France
Nantes, Loire Atlantique, France
Angers, Maine Et Loire, France
Pessac, Nouvelle Aquitaine, France
Montpellier, Occitanie, France
Clermont Ferrand, Puy De Dôme, France
Lyon, Rhône Alpes, France
Wiesbaden, Hessen, Germany
Leipzig, Sachsen, Germany
Berlin, , Germany
Budapest, Central Hungary, Hungary
Debrecen, Hajdu Bihar County, Hungary
Debrecen, Hajdú Bihar, Hungary
Jerusalem, Jerusalem District, Israel
Nahariya, Northern District, Israel
Be'er Sheva, Southern District, Israel
Cuauhtémoc, Ciudad De México, Mexico
Monterrey, Nuevo León, Mexico
Tilburg, North Brabant, Netherlands
Uden, North Brabent, Netherlands
Wrocław, Dolnoslaskie, Poland
Wrocław, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Mysłowice, Silesian Voivodeship, Poland
Katowice, Slaskie, Poland
Poznań, Wielkopolskie, Poland
łódź, łódzkie, Poland
Czestochowa, śląskie, Poland
Guimarães, Braga, Portugal
Lisboa, , Portugal
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Pretoria, , South Africa
Palma De Mallorca, Balearic Islands, Spain
Pontevedra, , Spain
Sevilla, , Spain
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
London, England, United Kingdom
Surrey Quays, England, United Kingdom
Glasgow, North Lanarkshire, United Kingdom
Little Rock, Arkansas, United States
Guangzhou, , China
Nanyang, Henan, China
Bologna, , Italy
Box Hill, Victoria, Australia
Miami, Florida, United States
Denison, Texas, United States
Poway, California, United States
Tianjin, Tianjin, China
Houma, Louisiana, United States
Birmingham, Alabama, United States
Tucson, Arizona, United States
Conway, Arkansas, United States
Adventura, Florida, United States
Pensacola, Florida, United States
Lagrange, Georgia, United States
Munster, Indiana, United States
Columbia, Missouri, United States
Dayton, Ohio, United States
El Paso, Texas, United States
Waco, Texas, United States
Liège, , Belgium
Haifa, Haifa District, Israel
Monterrey, Nuevo León, Mexico
Amsterdam, Noord Holland, Netherlands
Senhora Da Hora, , Portugal
Viana Do Castelo, , Portugal
San Juan, , Puerto Rico
Pretoria, Gauteng, South Africa
Cuauhtémoc, , Mexico
West Columbia, South Carolina, United States
Lancaster, California, United States
Thousand Oaks, California, United States
Miami, Florida, United States
College Park, Georgia, United States
Hammond, Indiana, United States
Lafayette, Louisiana, United States
Wyoming, Michigan, United States
Dallas, Texas, United States
Georgetown, Texas, United States
Houston, Texas, United States
Manassas, Virginia, United States
Terrebonne, Quebec, Canada
La Serena, Coquimbo, Chile
Santiago, , Chile
Budapest, , Hungary
Tel Aviv, Gush Dan, Israel
Fountain Valley, California, United States
Lehigh Acres, Florida, United States
Plantation, Florida, United States
Metairie, Louisiana, United States
Pittsburgh, Pennsylvania, United States
Budapest, , Hungary
Querétaro, , Mexico
Newcastle Upon Tyne, England, United Kingdom
Rosario, Santa Fe, Mexico
Tucson, Arizona, United States
Bakersfield, California, United States
Huntington Park, California, United States
Miami, Florida, United States
Palmetto Bay, Florida, United States
Mentor, Ohio, United States
Angers Cedex 9, Maine Et Loire, France
Lübeck, Schleswig Holstein, Germany
Guadalajara, Jalisco, Mexico
Cuernavaca, Morelos, Mexico
Vila Real, , Portugal
Mcallen, Texas, United States
Dijon, Cantal, France
Sheffield, England, United Kingdom
Zephyrhills, Florida, United States
Mcallen, Texas, United States
New York, New York, United States
Buenos Aires, Buenos Aries, Argentina
Milano, Milan, Italy
Mérida, Yucatan, Mexico
Pasadena, California, United States
Sanmenxia, Henan, China
Hangzhou, Zhejiang, China
San Antonio, Texas, United States
Northeim, , Germany
Metepec, , Mexico
Orlando, Florida, United States
Wellington, Florida, United States
Houston, Texas, United States
Lubbock, Texas, United States
Mansfield, Texas, United States
Webster, Texas, United States
Chongqing, Chongging, China
Chongqing, Chongging, China
Beijing, Fengtai, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Zhenjiang, Jiangsu, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Taiyuan, Shanxi, China
Chengdu, Sichuan Shi, China
Ruian, Zhejiang, China
Changsha, , China
Fuzhou, , China
Hangzhou, , China
Heping, , China
Roma, , Italy
Ciudad De Mexico, , Mexico
Metepec, , Mexico
Metepec, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Zumpango, , Mexico
Las Vegas, Nevada, United States
Winston Salem, North Carolina, United States
Dublin, Ohio, United States
Richmond, Virginia, United States
Ciudad De México, , Mexico
Ningbo, , China
Viña Del Mar, , Chile
Nice, , France
Ribeirão Preto, , Brazil
Debrecen, , Hungary
Monterrey, , Mexico
Monterrey, , Mexico
łódź, , Poland
Czestochowa, , Poland
Patients applied
Trial Officials
Arun J Sanyal, MD
Principal Investigator
VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
Sven Francque, MD
Principal Investigator
Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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